The following data is part of a premarket notification filed by Stiefel Research Institute, Inc. with the FDA for Hermal Wound Care Kit.
| Device ID | K895817 |
| 510k Number | K895817 |
| Device Name: | HERMAL WOUND CARE KIT |
| Classification | Dressing, Wound, Drug |
| Applicant | STIEFEL RESEARCH INSTITUTE, INC. Oak Hill, NY 12460 |
| Contact | Carr, Jr. |
| Correspondent | Carr, Jr. STIEFEL RESEARCH INSTITUTE, INC. Oak Hill, NY 12460 |
| 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 | 1989-09-29 |
| Decision Date | 1990-01-19 |