The following data is part of a premarket notification filed by Dermatec, Inc. with the FDA for Dermatec Zone Transparent Dressing.
| Device ID | K863578 |
| 510k Number | K863578 |
| Device Name: | DERMATEC ZONE TRANSPARENT DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | DERMATEC, INC. 91 BUNKER HILL DR. Trumbull, CT 06611 |
| Contact | Steven M Tuchband |
| Correspondent | Steven M Tuchband DERMATEC, INC. 91 BUNKER HILL DR. Trumbull, CT 06611 |
| 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 | 1986-11-25 |