The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Duoderm Transparent Hydrocolloid Dressing.
| Device ID | K925992 |
| 510k Number | K925992 |
| Device Name: | DUODERM TRANSPARENT HYDROCOLLOID DRESSING |
| Classification | Device, Intravascular Catheter Securement |
| 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 | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-25 |
| Decision Date | 1993-10-15 |