The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Hydroxylapatite Bone Graft Material.
| Device ID | K863237 |
| 510k Number | K863237 |
| Device Name: | HYDROXYLAPATITE BONE GRAFT MATERIAL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-21 |
| Decision Date | 1986-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925022416 | K863237 | 000 |
| 00821925022409 | K863237 | 000 |
| 00821925021471 | K863237 | 000 |
| 00821925021464 | K863237 | 000 |
| 00821925021457 | K863237 | 000 |
| 00821925021433 | K863237 | 000 |
| 00821925015579 | K863237 | 000 |