The following data is part of a premarket notification filed by Friatec Medical Inc., Usa with the FDA for Frialit(r)-2 Stepped Screw With Deep Profile Surface.
| Device ID | K945847 |
| 510k Number | K945847 |
| Device Name: | FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE |
| Classification | Implant, Endosseous, Root-form |
| Applicant | FRIATEC MEDICAL INC., USA 9229 CRANFORD DR. Potomac, MD 20854 |
| Contact | Robert J Slomoff |
| Correspondent | Robert J Slomoff FRIATEC MEDICAL INC., USA 9229 CRANFORD DR. Potomac, MD 20854 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-30 |
| Decision Date | 1996-03-15 |