The following data is part of a premarket notification filed by Springfield Surgical Instruments with the FDA for Brimfield Precision Grasper/dissector.
| Device ID | K933387 |
| 510k Number | K933387 |
| Device Name: | BRIMFIELD PRECISION GRASPER/DISSECTOR |
| 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 | 1993-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B33158750000 | K933387 | 000 |
| B33158721300 | K933387 | 000 |
| B33158621100 | K933387 | 000 |
| B33158620200 | K933387 | 000 |