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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 K875193
Device Name INDISTRIP (STERILIZATION PROCESS INDICATOR)
Applicant
Indilab, Inc.
8010 Salisbury
Lyons,  IL  60534
Applicant Contact ROBERT GAVRICK
Correspondent
Indilab, Inc.
8010 Salisbury
Lyons,  IL  60534
Correspondent Contact ROBERT GAVRICK
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received12/17/1987
Decision Date 03/31/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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