The following data is part of a premarket notification filed by Blairden Precision Instruments, Inc. with the FDA for Surgical Saw Blades.
Device ID | K912761 |
510k Number | K912761 |
Device Name: | SURGICAL SAW BLADES |
Classification | Blade, Saw, General & Plastic Surgery, Surgical |
Applicant | BLAIRDEN PRECISION INSTRUMENTS, INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
Contact | Richard Hamer |
Correspondent | Richard Hamer BLAIRDEN PRECISION INSTRUMENTS, INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
Product Code | GFA |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-24 |
Decision Date | 1991-07-19 |