The following data is part of a premarket notification filed by Sterling Drug, Inc. with the FDA for Green Label Biobrane Ii And Red Label Biobrane Ii.
| Device ID | K901369 |
| 510k Number | K901369 |
| Device Name: | GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II |
| Classification | Dressing, Wound, Drug |
| Applicant | STERLING DRUG, INC. 90 PARK AVE. New York, NY 10016 |
| Contact | Linda L Nardone,phd |
| Correspondent | Linda L Nardone,phd STERLING DRUG, INC. 90 PARK AVE. New York, NY 10016 |
| 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 | 1990-03-23 |
| Decision Date | 1990-06-05 |