K895207 is an FDA 510(k) clearance for the BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM. This device is classified as a Dressing, Wound, Drug.
Submitted by Johnson & Johnson International (New Brunswick, US). The FDA issued a Cleared decision on September 28, 1989, 42 days after receiving the submission on August 17, 1989.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K895207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1989 |
| Decision Date | September 28, 1989 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |