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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sterilant, medical devices
510(k) Number K120306
Device Name RAPICIDE OPA-28
Original Applicant
14605 28th ave. north
minneapolis,  MN  55447
Original Contact brent greiger, ms, rac
Regulation Number880.6885
Classification Product Code
Date Received02/01/2012
Decision Date 09/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No