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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 K113221
Device Name NAMSA BIOLOGICAL INDICATOR SPORE STRIPS
Applicant
NORTH AMERICAN SCIENCE ASSOC., INC.
6750 WALES RD.
NORTHWOOD,  OH  43619
Applicant Contact JULIE WHEELER
Correspondent
NORTH AMERICAN SCIENCE ASSOC., INC.
6750 WALES RD.
NORTHWOOD,  OH  43619
Correspondent Contact JULIE WHEELER
Regulation Number880.2800
Classification Product Code
FRC  
Date Received11/01/2011
Decision Date 04/27/2012
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
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