The following data is part of a premarket notification filed by Amsco Sterile Recoveries, Inc. with the FDA for Reusable Liquidproof Bootie.
| Device ID | K925815 |
| 510k Number | K925815 |
| Device Name: | REUSABLE LIQUIDPROOF BOOTIE |
| Classification | Cover, Shoe, Operating-room |
| 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 | FXP |
| Subsequent Product Code | FXW |
| Subsequent Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-17 |
| Decision Date | 1993-07-09 |