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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 K132372
Device Name STERITEC GREEN CARD PACK BOWIE-DICK TEST
Applicant
Steritec Products Mfg Co, Inc.
74 Inverness Dr. E.
Engelwood,  CO  80112
Applicant Contact JONATHAN RUTIGLIANO
Correspondent
Steritec Products Mfg Co, Inc.
74 Inverness Dr. E.
Engelwood,  CO  80112
Correspondent Contact JONATHAN RUTIGLIANO
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received07/30/2013
Decision Date 11/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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