Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name sterilizer, steam
510(k) Number K112403
Device Name AMSCO CHIMERON MEDIUM STEAM STERLILZER
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact ROBERT F SULLIVAN
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact ROBERT F SULLIVAN
Regulation Number880.6880
Classification Product Code
FLE  
Date Received08/22/2011
Decision Date 05/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-