The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Chimeron Medium Steam Sterilizer.
Device ID | K112055 |
510k Number | K112055 |
Device Name: | AMSCO CHIMERON MEDIUM 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-19 |
Decision Date | 2011-12-16 |
Summary: | summary |