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 |