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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 K133322
Device Name STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
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
FRC  
Date Received10/29/2013
Decision Date 08/25/2014
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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