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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 K003002
Device Name STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123
Applicant
Steritec Products, Inc.
599 Topeka Way, Suite 700
Castle Rock,  CO  80104
Applicant Contact LINDA NELSON
Correspondent
Steritec Products, Inc.
599 Topeka Way, Suite 700
Castle Rock,  CO  80104
Correspondent Contact LINDA NELSON
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received09/26/2000
Decision Date 12/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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