The following data is part of a premarket notification filed by Amsco Sterile Recoveries, Inc. with the FDA for Surgical Drape.
| Device ID | K921049 |
| 510k Number | K921049 |
| Device Name: | SURGICAL DRAPE |
| Classification | Drape, Surgical |
| Applicant | AMSCO STERILE RECOVERIES, INC. 28100 U.S. HWY, 19N., STE. 201 Clearwater, FL 34621 |
| Contact | Denise A Schottler |
| Correspondent | Denise A Schottler AMSCO STERILE RECOVERIES, INC. 28100 U.S. HWY, 19N., STE. 201 Clearwater, FL 34621 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-05 |
| Decision Date | 1992-10-01 |