The following data is part of a premarket notification filed by Medpac with the FDA for Sfc.
Device ID | K951303 |
510k Number | K951303 |
Device Name: | SFC |
Classification | Screw, Fixation, Bone |
Applicant | MEDPAC 25768 PARADA DR. Valencia, CA 91355 |
Contact | Robert J Medoff |
Correspondent | Robert J Medoff MEDPAC 25768 PARADA DR. Valencia, CA 91355 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-22 |
Decision Date | 1995-06-27 |