The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Hydrocolloid Wound Dressing.
| Device ID | K943258 |
| 510k Number | K943258 |
| Device Name: | HYDROCOLLOID WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Karen Horgan |
| Correspondent | Karen Horgan CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-06 |
| Decision Date | 1994-08-04 |