The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Actiderm (tm) Dermatological Patch.
| Device ID | K895376 |
| 510k Number | K895376 |
| Device Name: | ACTIDERM (TM) DERMATOLOGICAL PATCH |
| Classification | Tape And Bandage, Adhesive |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
| Contact | Mark Citron |
| Correspondent | Mark Citron 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 | 1989-08-30 |
| Decision Date | 1989-09-25 |