The following data is part of a premarket notification filed by Fred C. Bryson with the FDA for Osteo Bone Screws.
Device ID | K913269 |
510k Number | K913269 |
Device Name: | OSTEO BONE SCREWS |
Classification | Screw, Fixation, Bone |
Applicant | FRED C. BRYSON 208 WILSON BRIDGE RD. Greenwood, SC 29646 |
Contact | Fred C Bryson |
Correspondent | Fred C Bryson FRED C. BRYSON 208 WILSON BRIDGE RD. Greenwood, SC 29646 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-23 |
Decision Date | 1991-11-22 |