The following data is part of a premarket notification filed by Polyclinic Medical Center with the FDA for Hard Tissue Replace(htr(r))-patient-match Implant.
| Device ID | K924935 |
| 510k Number | K924935 |
| Device Name: | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT |
| Classification | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Applicant | POLYCLINIC MEDICAL CENTER P.O. BOX 587 Warsaw, IN 46581 |
| Contact | Mary L Verstynen |
| Correspondent | Mary L Verstynen POLYCLINIC MEDICAL CENTER P.O. BOX 587 Warsaw, IN 46581 |
| Product Code | KKY |
| Subsequent Product Code | FWP |
| Subsequent Product Code | FZE |
| Subsequent Product Code | LZK |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-30 |
| Decision Date | 1993-09-02 |