The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Duoderm Sustained Compression Bandage.
| Device ID | K920675 |
| 510k Number | K920675 |
| Device Name: | DUODERM SUSTAINED COMPRESSION BANDAGE |
| Classification | Tape And Bandage, Adhesive |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
| Contact | Steven Peltier |
| Correspondent | Steven Peltier 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 | 1992-02-14 |
| Decision Date | 1992-08-18 |