The following data is part of a premarket notification filed by Biosystems Assoc. with the FDA for Omiderm Wound & Burn Dressing.
| Device ID | K851885 |
| 510k Number | K851885 |
| Device Name: | OMIDERM WOUND & BURN DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | BIOSYSTEMS ASSOC. PROSPECT PLAZA P.O. BOX 144 La Jolla, CA 92038 |
| Contact | Elie A Shneour |
| Correspondent | Elie A Shneour BIOSYSTEMS ASSOC. PROSPECT PLAZA P.O. BOX 144 La Jolla, CA 92038 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-30 |
| Decision Date | 1985-11-25 |