The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Skincote.
| Device ID | K882567 |
| 510k Number | K882567 |
| Device Name: | SKINCOTE |
| Classification | Dressing, Wound, Drug |
| Applicant | DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Contact | D Schattner |
| Correspondent | D Schattner DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-22 |
| Decision Date | 1988-10-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SKINCOTE 73290625 1262177 Dead/Cancelled |
Dynamed Corporation 1980-12-22 |