The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Mri Patient Positioning Devices.
| Device ID | K080072 |
| 510k Number | K080072 |
| Device Name: | MRI PATIENT POSITIONING DEVICES |
| Classification | Accelerator, Linear, Medical |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward CIVCO MEDICAL INSTRUMENTS CO., INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-11 |
| Decision Date | 2008-06-04 |
| Summary: | summary |