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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name indicator, biological sterilization process
510(K) Number K113302
Model MSCS-05R
Device Name NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS
Applicant
NORTH AMERICAN SCIENCE ASSOC., INC.
6750 wales rd.
northwood,  OH  43619
Contact julie wheeler
Regulation Number880.2800
Classification Product Code
FRC  
Date Received11/08/2011
Decision Date 01/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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