The following data is part of a premarket notification filed by Bioderm, Inc. with the FDA for Btf Thin Film Wound Dressing.
| Device ID | K982939 |
| 510k Number | K982939 |
| Device Name: | BTF THIN FILM WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | BIODERM, INC. 9705 INTERNATIONAL CT. NORTH St. Petersburg, FL 33716 -4807 |
| Contact | Marie B Teixeira |
| Correspondent | Marie B Teixeira BIODERM, INC. 9705 INTERNATIONAL CT. NORTH St. Petersburg, FL 33716 -4807 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-21 |
| Decision Date | 1998-10-13 |
| Summary: | summary |