The following data is part of a premarket notification filed by Cytophil Inc with the FDA for Periophil Biphasic.
| Device ID | K092788 |
| 510k Number | K092788 |
| Device Name: | PERIOPHIL BIPHASIC |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | CYTOPHIL INC 2485 CORPORATE CIRCLE UNIT 2 East Troy, WI 53120 |
| Contact | Victor M Bowers |
| Correspondent | Victor M Bowers CYTOPHIL INC 2485 CORPORATE CIRCLE UNIT 2 East Troy, WI 53120 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-10 |
| Decision Date | 2009-12-18 |
| Summary: | summary |