The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Duoderm(r) Adhesive Compression Bandage, Modified.
| Device ID | K912550 | 
| 510k Number | K912550 | 
| Device Name: | DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED | 
| Classification | Tape And Bandage, Adhesive | 
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 | 
| Contact | Marilyn Dreyling | 
| Correspondent | Marilyn Dreyling 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 | 1991-06-10 | 
| Decision Date | 1991-08-14 |