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 |