The following data is part of a premarket notification filed by Bioderm, Inc. with the FDA for Rubycell(tm) Synthetic Island Dressing.
| Device ID | K870352 |
| 510k Number | K870352 |
| Device Name: | RUBYCELL(TM) SYNTHETIC ISLAND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | BIODERM, INC. P.O. BOX 4882 Wheaton, IL 60189 |
| Contact | Olivier A Delannoy |
| Correspondent | Olivier A Delannoy BIODERM, INC. P.O. BOX 4882 Wheaton, IL 60189 |
| 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 | 1987-01-29 |
| Decision Date | 1987-02-26 |