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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Chemical, Enzymatic, Sterilization Process
510(k) Number K210481
Device Name Instant 20s Indicator
Applicant
True Indicating, LLC
946 Kane St.
Toledo,  OH  43612
Applicant Contact Thomas Riha
Correspondent
True Indicating, LLC
946 Kane St.
Toledo,  OH  43612
Correspondent Contact Thomas Riha
Regulation Number880.2800
Classification Product Code
MTC  
Date Received02/19/2021
Decision Date 12/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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