The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Vitagel Surgical Hemostat Spray Set.
| Device ID | K052173 |
| 510k Number | K052173 |
| Device Name: | VITAGEL SURGICAL HEMOSTAT SPRAY SET |
| Classification | Syringe, Piston |
| Applicant | ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Gina M Nagvajara |
| Correspondent | Gina M Nagvajara ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-08-10 |
| Decision Date | 2005-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30808232000833 | K052173 | 000 |