The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Warming Cabinet.
Device ID | K111870 |
510k Number | K111870 |
Device Name: | AMSCO WARMING CABINET |
Classification | Warmer, Thermal, Infusion Fluid |
Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | Robert F Sullivan |
Correspondent | Robert F Sullivan STERIS Corporation 5960 Heisley Road 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 | 2011-07-01 |
Decision Date | 2011-07-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00724995154189 | K111870 | 000 |