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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Disinfectant, Medical Devices
510(k) Number K983947
Device Name AMERSE 2
Applicant
STERIS Corporation
5035 Manchester Ave.
St. Louis,  MO  63110
Applicant Contact MICHAEL G SARLI
Correspondent
STERIS Corporation
5035 Manchester Ave.
St. Louis,  MO  63110
Correspondent Contact MICHAEL G SARLI
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received11/05/1998
Decision Date 12/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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