The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Warming Cabinet.
| Device ID | K110769 |
| 510k Number | K110769 |
| Device Name: | AMSCO WARMING CABINET |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | STERIS Corporation 5960 HEISLEY Mentor, OH 44060 |
| Contact | Robert F Sullivan |
| Correspondent | Robert F Sullivan STERIS Corporation 5960 HEISLEY Mentor, OH 44060 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-18 |
| Decision Date | 2011-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995154172 | K110769 | 000 |