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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 K040901
Device Name STERITEC EMU-GRAPH, MODEL NO. CI 131/US
Applicant
Steritec Products, Inc.
599 Topeka Way
Suite 400
Castle Rock,  CO  80109
Applicant Contact LINDA NELSON
Correspondent
Steritec Products, Inc.
599 Topeka Way
Suite 400
Castle Rock,  CO  80109
Correspondent Contact LINDA NELSON
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received04/07/2004
Decision Date 09/09/2004
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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