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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 K043482
Device Name THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact MARGARET MARSH
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received12/17/2004
Decision Date 12/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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