The following data is part of a premarket notification filed by Johnson & Johnson International with the FDA for Bioclusive* Transparent Film Dressing - New Claim.
| Device ID | K895207 |
| 510k Number | K895207 |
| Device Name: | BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM |
| Classification | Dressing, Wound, Drug |
| Applicant | JOHNSON & JOHNSON INTERNATIONAL 410 GEORGE ST. New Brunswick, NJ 08901 |
| Contact | Omega Norton-crable |
| Correspondent | Omega Norton-crable JOHNSON & JOHNSON INTERNATIONAL 410 GEORGE ST. New Brunswick, NJ 08901 |
| 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 | 1989-08-17 |
| Decision Date | 1989-09-28 |