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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K231383
Device Name Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), 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 Ln.
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number880.2800
Classification Product Code
FRC  
Subsequent Product Code
JOJ  
Date Received05/12/2023
Decision Date 09/18/2024
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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