The following data is part of a premarket notification filed by Dermatec, Inc. with the FDA for Dermatec Transparent Film Dressing.
Device ID | K863580 |
510k Number | K863580 |
Device Name: | DERMATEC TRANSPARENT FILM DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | DERMATEC, INC. 549 HOWE AVE. Shelton, CT 06484 |
Contact | Steven M Tuchband |
Correspondent | Steven M Tuchband DERMATEC, INC. 549 HOWE AVE. Shelton, CT 06484 |
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 | 1986-08-28 |
Decision Date | 1986-12-31 |