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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 K122945
Model BD126
Device Name STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
Applicant
STERITEC PRODUCTS MFG. CO., INC.
74 inverness drive east
englewood,  CO  80112
Contact jonathan rutigliano
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received09/24/2012
Decision Date 04/30/2013
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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