The following data is part of a premarket notification filed by Amsco Sterile Recoveries, Inc. with the FDA for Sterile Surgeon's Gown, Modification.
| Device ID | K931144 |
| 510k Number | K931144 |
| Device Name: | STERILE SURGEON'S GOWN, MODIFICATION |
| Classification | Gown, 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 | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-05 |
| Decision Date | 1994-06-10 |