The following data is part of a premarket notification filed by Springfield Surgical Instruments with the FDA for Brimfield Precision Fan Retractor.
| Device ID | K941316 |
| 510k Number | K941316 |
| Device Name: | BRIMFIELD PRECISION FAN RETRACTOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SPRINGFIELD SURGICAL INSTRUMENTS MILL LN. RD. Brimfield, MA 01010 |
| Contact | Jamy Gannoe |
| Correspondent | Jamy 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 | 1994-03-18 |
| Decision Date | 1994-04-22 |