The following data is part of a premarket notification filed by Alliance Medical, Inc. with the FDA for Disposable Ama Sterile Drape Sheet, Cat. No. 5252.
| Device ID | K931091 |
| 510k Number | K931091 |
| Device Name: | DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252 |
| Classification | Drape, Surgical |
| Applicant | ALLIANCE MEDICAL, INC. POST OFFICE BOX 1029 Santa Ynez, CA 93460 |
| Contact | Pamela G Goforth |
| Correspondent | Pamela G Goforth ALLIANCE MEDICAL, INC. POST OFFICE BOX 1029 Santa Ynez, CA 93460 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-03 |
| Decision Date | 1994-02-03 |