K031089 is an FDA 510(k) clearance for the GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by W.L. Gore & Associates, Inc. (Newark, US). The FDA issued a Cleared decision on May 8, 2003, 31 days after receiving the submission on April 7, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K031089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2003 |
| Decision Date | May 08, 2003 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MOS — Coil, Magnetic Resonance, Specialty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |