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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name A Chemical Vapor Sterilization Multivariable Chemical Indicator
510(k) Number K232103
Device Name Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
Applicant
Terragene S.A.
Ruta Nacional # 9, Km 280, Parque Industrial Micropi
Alvear,  AR 2130
Applicant Contact Hernando Carrizo
Correspondent
Licensale, Inc.
3422 Leonardo Lane
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number880.2800
Classification Product Code
QKM  
Subsequent Product Code
JOJ  
Date Received07/14/2023
Decision Date 04/05/2024
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
Predetermined Change
Control Plan Authorized		 No
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