The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Mini Flex Coil.
| Device ID | K961628 |
| 510k Number | K961628 |
| Device Name: | MINI FLEX COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | W.L. GORE & ASSOCIATES,INC 4747 EAST BEAUTIFUL LN. Phoenix, AZ 85044 |
| Contact | Ken Davis |
| Correspondent | Ken Davis W.L. GORE & ASSOCIATES,INC 4747 EAST BEAUTIFUL LN. Phoenix, AZ 85044 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-26 |
| Decision Date | 1996-09-05 |
| Summary: | summary |