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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 K931477
Device Name AMERSE
Applicant
CALGON VESTAL DIV.
P.O. BOX 147
ST.LOUIS,  MO  63166 -0147
Applicant Contact MICHAEL EBERS
Correspondent
CALGON VESTAL DIV.
P.O. BOX 147
ST.LOUIS,  MO  63166 -0147
Correspondent Contact MICHAEL EBERS
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received03/24/1993
Decision Date 06/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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