The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Wound Manager(tm) - Sterile.
Device ID | K862935 |
510k Number | K862935 |
Device Name: | WOUND MANAGER(TM) - STERILE |
Classification | Dressing, Wound, Drug |
Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
Contact | Peter C Kallos |
Correspondent | Peter C Kallos CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-04 |
Decision Date | 1986-08-20 |