The following data is part of a premarket notification filed by Poly-medics,inc. with the FDA for Hard Tissue Replacement (htr) Granular.
| Device ID | K934861 |
| 510k Number | K934861 |
| Device Name: | HARD TISSUE REPLACEMENT (HTR) GRANULAR |
| Classification | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Applicant | POLY-MEDICS,INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary L Verstynen |
| Correspondent | Mary L Verstynen POLY-MEDICS,INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KKY |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1994-11-04 |