The following data is part of a premarket notification filed by Brimfield Scientific Instruments with the FDA for Brimfield Cannulated Blade Holder.
Device ID | K852042 |
510k Number | K852042 |
Device Name: | BRIMFIELD CANNULATED BLADE HOLDER |
Classification | Handle, Scalpel |
Applicant | BRIMFIELD SCIENTIFIC INSTRUMENTS MILL LN. RD. Brimfield, MA 01010 |
Contact | David W Antonopoulo |
Correspondent | David W Antonopoulo BRIMFIELD SCIENTIFIC INSTRUMENTS MILL LN. RD. Brimfield, MA 01010 |
Product Code | GDZ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-09 |
Decision Date | 1985-06-11 |