The following data is part of a premarket notification filed by Brimfield Scientific Instruments with the FDA for Brimfield Cannulated Grasping Hooks.
Device ID | K843136 |
510k Number | K843136 |
Device Name: | BRIMFIELD CANNULATED GRASPING HOOKS |
Classification | Hook, Surgical, General & Plastic Surgery |
Applicant | BRIMFIELD SCIENTIFIC INSTRUMENTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GDG |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-09 |
Decision Date | 1984-09-25 |