The following data is part of a premarket notification filed by Osteogenics Co. with the FDA for Cytoplast Gbr.
| Device ID | K964342 |
| 510k Number | K964342 |
| Device Name: | CYTOPLAST GBR |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | OSTEOGENICS CO. 100 EAST 15TH STREET,SUITE 320 Forth Worth, TX 76102 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer OSTEOGENICS CO. 100 EAST 15TH STREET,SUITE 320 Forth Worth, TX 76102 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-31 |
| Decision Date | 1997-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844868042174 | K964342 | 000 |
| 00844868042167 | K964342 | 000 |
| 00844868042150 | K964342 | 000 |
| 00844868042143 | K964342 | 000 |
| 00844868041436 | K964342 | 000 |
| 00844868041429 | K964342 | 000 |
| EFRIOSNRM25301 | K964342 | 000 |
| EFRIOSNRM12241 | K964342 | 000 |