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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 K083650
Device Name EMU-GRAPH 4 EMULATOR, MODEL CI 144
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 Received12/09/2008
Decision Date 03/05/2009
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
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