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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 K012732
Device Name INTEGRAPH FLASH, MODEL CI 110
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 Received08/16/2001
Decision Date 03/04/2002
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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