The following data is part of a premarket notification filed by Amsco Sterile Recoveries, Inc. with the FDA for Autoclavable Reusable Wrap -- Centeral Service Use.
| Device ID | K931875 |
| 510k Number | K931875 |
| Device Name: | AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE |
| Classification | Wrap, Sterilization |
| 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 | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-14 |
| Decision Date | 1994-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812564039569 | K931875 | 000 |
| 00812564039552 | K931875 | 000 |
| 00812564039545 | K931875 | 000 |
| 00812564039538 | K931875 | 000 |
| 00812564034274 | K931875 | 000 |