The following data is part of a premarket notification filed by Cp Medical with the FDA for Oscera7 Synthetic Absorbable Bone Wax, Model Os31.
| Device ID | K060987 |
| 510k Number | K060987 |
| Device Name: | OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 |
| Classification | Wax, Bone |
| Applicant | CP MEDICAL 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518 |
| Contact | Betsy Cortelloni |
| Correspondent | Betsy Cortelloni CP MEDICAL 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518 |
| Product Code | MTJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-10 |
| Decision Date | 2006-11-02 |
| Summary: | summary |