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 |