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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 K162413
Device Name AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
Applicant
STERIS Corporation
5960 Heisley Rd
Mentor,  OH  44060
Applicant Contact Bill Brodbeck
Correspondent
STERIS Corporation
5960 Heisley Rd
Mentor,  OH  44060
Correspondent Contact Bill Brodbeck
Regulation Number880.6860
Classification Product Code
MLR  
Date Received08/29/2016
Decision Date 03/31/2017
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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