The following data is part of a premarket notification filed by Cytophil Inc with the FDA for Osteophil Beta-tcp.
| Device ID | K102937 |
| 510k Number | K102937 |
| Device Name: | OSTEOPHIL BETA-TCP |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | CYTOPHIL INC 2485 CORPORATE CIRCLE SUITE 2 East Troy, WI 53120 |
| Contact | Victor M Bowers |
| Correspondent | Victor M Bowers CYTOPHIL INC 2485 CORPORATE CIRCLE SUITE 2 East Troy, WI 53120 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-04 |
| Decision Date | 2010-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842166115484 | K102937 | 000 |