The following data is part of a premarket notification filed by Superior Medical Products with the FDA for Eazy Covers.
| Device ID | K863853 |
| 510k Number | K863853 |
| Device Name: | EAZY COVERS |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SUPERIOR MEDICAL PRODUCTS POST OFFICE BOX 71987 Marietta, GA 30007 |
| Contact | Cottone, Jr. |
| Correspondent | Cottone, Jr. SUPERIOR MEDICAL PRODUCTS POST OFFICE BOX 71987 Marietta, GA 30007 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-02 |
| Decision Date | 1987-03-06 |