The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Synergy Shoulder Coil.
| Device ID | K991765 |
| 510k Number | K991765 |
| Device Name: | SYNERGY SHOULDER COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 -0197 |
| Contact | Peter Altman |
| Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 -0197 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-24 |
| Decision Date | 1999-08-02 |
| Summary: | summary |