The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Chimeron Small Steam Sterilizer.
Device ID | K111223 |
510k Number | K111223 |
Device Name: | AMSCO CHIMERON SMALL STEAM STERILIZER |
Classification | Sterilizer, Steam |
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 | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-02 |
Decision Date | 2011-09-20 |
Summary: | summary |