The following data is part of a premarket notification filed by Springfield Surgical Instruments with the FDA for Brimfield Precision Scissor.
Device ID | K933388 |
510k Number | K933388 |
Device Name: | BRIMFIELD PRECISION SCISSOR |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | SPRINGFIELD SURGICAL INSTRUMENTS MILL LN. RD. Brimfield, MA 01010 |
Contact | Matthew Lyons |
Correspondent | Matthew Lyons SPRINGFIELD SURGICAL INSTRUMENTS MILL LN. RD. Brimfield, MA 01010 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-12 |
Decision Date | 1993-10-21 |