Vintage Autoclave Wilmot Castle Co .made In Usa Tattoo Artist Cool Look

US $1700

Waterbury, Connecticut, United States
Nov 17th

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VINTAGE WILMOT CASTLE STAINLESS STERILIZER NICE COMPACT TABLE TOP MACHINE .14 INCHES LONG BY 12 INCHES HIGH 110 VOLT .OVERALL CLEAN MACHINE INSIDE HAS A 3 RACK SHELF WITH 2 STAINLESS SHELF'S . I BOUGHT IT FROM A LOCAL ESTATE SALE ,I HAVE NOT TRIED IT ,BUT I WAS TOLD IT FIRES UP YOU HAVE TO HAVE SOME KNOWLEDGE ABOUT THIS AND ITS CORRECT OPERATION. OVERALL IT LOOKS CLEAN THE FRONT CHROME RING HAS SOME PITTING ,THIS IS NORMAL BECAUSE OF THE STEAM THAT IS RELEASED WHEN OPENING IT UP WHEN ITS HOT . NICE MACHINE TO STERILIZE YOUR TATTOO EQUIPMENT OR OTHER MEDICAL TOOLS . ITS OLD AND IT SELLS AS IS AS DESCRIBED . PLEASE SEE THE PICTURE ASK QUESTIONS . NO RESERVE SHIPS IN USA FOR 26.00 ..OR BUY IT NOW . When a 510(k) is Not Required The following are examples of when a 510(k) is not required. You sell unfinished devices to another firm for further processing or sell components to be used in the assembling of devices by other firms. However, if your components are to be sold directly to end users as replacement parts, a 510(k) is required. Your device is not being marketed or commercially distributed. You do not need a 510(k) to develop, evaluate, or test a device. This includes clinical evaluation. Please note that if you perform clinical trials with your device, you are subject to the Investigational Device Exemption (IDE) regulation (21 CFR 812). You distribute another firm's domestically manufactured device. You may place a label on the device, "Distributed by ABC Firm" or "Manufactured for ABC Firm," (21 CFR 801.1) and sell it to end users without submission of a 510(k). In most cases, if you are a repackager or a relabeler you are not required to submit a 510(k) if the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications. Your device was legally in commercial distribution before May 28, 1976 and you have documentation to prove this. These devices are "grandfathered" and have Preamendment Status. You do not have to submit a 510(k) unless the device has been significantly modified or there has been a change in its intended use. The device is made outside the U.S. and you are an importer of the foreign made medical device. A 510(k) is not required if a 510(k) has been submitted by the foreign manufacturer and received marketing clearance. Once the foreign manufacturer has received 510(k) clearance for the device, the foreign manufacturer may export his device to any U.S. importer. Your device is exempted from 510(k) by regulation (21 CFR 862-892). That is, certain Class I or II devices can be marketed for the first time without having to submit a 510(k). A list of the Class I and II exempted devices can be found on Medical Device Exemptions 510(k) and GMP Requirements. However, if the device exceeds the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9), such as the device has a new intended use or operates using a different fundamental scientific technology than a legally marketed device in that generic type of device, or the device is a reprocessed single-use device, then a 510(k) must be submitted to market the new device.