K901369 is an FDA 510(k) clearance for the GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Sterling Drug, Inc. (New York, US). The FDA issued a Cleared decision on June 5, 1990, 74 days after receiving the submission on March 23, 1990.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K901369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1990 |
| Decision Date | June 05, 1990 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KGN — Wound Dressing With Animal-derived Material(s) |
| Device Class | — |