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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 K103000
Device Name SMART READ BIOLOGICAL TEST PACK
Applicant
Steritec Products Mfg Co, Inc.
74 Inverness Dr. E.
Engelwood,  CO  80112
Applicant Contact SUZANNE DENNIS
Correspondent
Steritec Products Mfg Co, Inc.
74 Inverness Dr. E.
Engelwood,  CO  80112
Correspondent Contact SUZANNE DENNIS
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received10/08/2010
Decision Date 02/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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