The following data is part of a premarket notification filed by Springfield Surgical Instruments with the FDA for Brimfield Precision Grasper/dissector.
Device ID | K946263 |
510k Number | K946263 |
Device Name: | BRIMFIELD PRECISION GRASPER/DISSECTOR |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | SPRINGFIELD SURGICAL INSTRUMENTS MILL LN. RD. Brimfield, MA 01010 |
Contact | James Gannoe |
Correspondent | James Gannoe 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 | 1994-12-23 |
Decision Date | 1995-01-26 |