The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Convatec Two Piece Absorbent Dressing System.
Device ID | K935948 |
510k Number | K935948 |
Device Name: | CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM |
Classification | Tape And Bandage, Adhesive |
Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
Contact | Adrienne Mcnally |
Correspondent | Adrienne Mcnally CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-13 |
Decision Date | 1994-03-01 |