The following data is part of a premarket notification filed by Fidia Pharmaceutical Corp. with the FDA for Bionect Cream.
| Device ID | K963004 |
| 510k Number | K963004 |
| Device Name: | BIONECT CREAM |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | FIDIA PHARMACEUTICAL CORP. 1401 EYE STREET, N.W. SUITE 900 Washington, DC 20005 |
| Contact | Roberto Fiorentini |
| Correspondent | Roberto Fiorentini FIDIA PHARMACEUTICAL CORP. 1401 EYE STREET, N.W. SUITE 900 Washington, DC 20005 |
| Product Code | MGQ |
| 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 | 1996-08-02 |
| Decision Date | 1997-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M713494440100350 | K963004 | 000 |
| M713494440025080 | K963004 | 000 |