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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sterilizer, chemical
510(k) Number K083097
Device Name AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
Applicant
STERIS Corporation
5960 Heisley Road
mentor,  OH  44060
Applicant Contact john r scoville
Correspondent
STERIS Corporation
5960 Heisley Road
mentor,  OH  44060
Correspondent Contact john r scoville
Regulation Number880.6860
Classification Product Code
MLR  
Date Received10/17/2008
Decision Date 08/03/2009
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
Recalls CDRH Recalls
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