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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name indicator, physical/chemical sterilization process
510(k) Number K122555
Model CI 159, CI 159/1, CI 159/5, CI 159/.75
Device Name STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE
Original Applicant
STERITEC PRODUCTS MFG. CO., INC.
74 inverness drive east
englewood,  CO  80112
Original Contact jonathan rutigliano
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received08/22/2012
Decision Date 12/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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