The following data is part of a premarket notification filed by Winfield Laboratories, Inc. with the FDA for Derma-aid.
| Device ID | K820198 |
| 510k Number | K820198 |
| Device Name: | DERMA-AID |
| Classification | Dressing, Wound, Drug |
| Applicant | WINFIELD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-25 |
| Decision Date | 1982-03-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DERMA-AID 78400113 not registered Dead/Abandoned |
Lucid Med Tec II, Ltd 2004-04-12 |