The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Remington Medical Disposable Fluoro/equipment Cover Model Rmi8.
| Device ID | K946060 |
| 510k Number | K946060 |
| Device Name: | REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8 |
| Classification | Drape, Surgical |
| Applicant | REMINGTON MEDICAL, INC. 8601 DUNWOODY PL., SUITE 510 Atlanta, GA 30350 |
| Contact | Fredrick L Aycock |
| Correspondent | Fredrick L Aycock REMINGTON MEDICAL, INC. 8601 DUNWOODY PL., SUITE 510 Atlanta, GA 30350 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-02 |
| Decision Date | 1995-04-27 |