The following data is part of a premarket notification filed by Contour Fabricators, Inc. with the FDA for Ge Sterile Disposable Equipment Coil Cover.
| Device ID | K964141 |
| 510k Number | K964141 |
| Device Name: | GE STERILE DISPOSABLE EQUIPMENT COIL COVER |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | CONTOUR FABRICATORS, INC. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Contact | Edward H Ransom |
| Correspondent | Edward H Ransom CONTOUR FABRICATORS, INC. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1997-01-30 |
| Summary: | summary |