The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Allkare(tm) Adhesive Remover Wipe.
Device ID | K924976 |
510k Number | K924976 |
Device Name: | ALLKARE(TM) ADHESIVE REMOVER WIPE |
Classification | Solvent, Adhesive Tape |
Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
Contact | Steven R Peltier |
Correspondent | Steven R Peltier CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
Product Code | KOX |
CFR Regulation Number | 878.4730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-01 |
Decision Date | 1993-04-20 |