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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 K072408
Device Name EMU-GRAPH EMULATOR, MODEL CI 131
Applicant
STERITEC PRODUCTS MFG. CO., INC.
599 TOPEKA WAY
SUITE 400
CASTLE ROCK,  CO  80109
Applicant Contact LINDA NELSON
Correspondent
STERITEC PRODUCTS MFG. CO., INC.
599 TOPEKA WAY
SUITE 400
CASTLE ROCK,  CO  80109
Correspondent Contact LINDA NELSON
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received08/27/2007
Decision Date 04/30/2008
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
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