The following data is part of a premarket notification filed by Fidia Pharmaceutical Corp. with the FDA for Bionect Hydrogel Spray.
| Device ID | K973724 |
| 510k Number | K973724 |
| Device Name: | BIONECT HYDROGEL SPRAY |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | FIDIA PHARMACEUTICAL CORP. 2000 K STREET,N.W SUITE 700 Washington, DC 20006 |
| Contact | Roberto Fiorentini |
| Correspondent | Roberto Fiorentini FIDIA PHARMACEUTICAL CORP. 2000 K STREET,N.W SUITE 700 Washington, DC 20006 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-30 |
| Decision Date | 1998-09-22 |
| Summary: | summary |