The following data is part of a premarket notification filed by Welmed Systems, Inc. with the FDA for T.p.n. Dressing Change Tray.
Device ID | K862219 |
510k Number | K862219 |
Device Name: | T.P.N. DRESSING CHANGE TRAY |
Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
Applicant | WELMED SYSTEMS, INC. P.O. BOX 599 West Swanzey, NH 03469 |
Contact | David B Peters |
Correspondent | David B Peters WELMED SYSTEMS, INC. P.O. BOX 599 West Swanzey, NH 03469 |
Product Code | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-11 |
Decision Date | 1986-07-08 |