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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 K112813
Device Name AMSCO V-PRO
Original Applicant
5960 heisley rd.
mentor,  OH  44060
Original Contact robert sullivan
Regulation Number880.6860
Classification Product Code
Date Received09/27/2011
Decision Date 12/01/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No