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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 K191021
Device Name Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
Applicant
Terragene SA
Ruta Nacional No. 9, Km 280, Parque Industrial Micropi
Alvear,  AR 2130
Applicant Contact Maria Victoria Rocha
Correspondent
Licensale Inc
68 Southwoods Terrace
Southbury,  CT  06488
Correspondent Contact Raymond Kelly
Regulation Number880.2800
Classification Product Code
FRC  
Subsequent Product Code
JOJ  
Date Received04/17/2019
Decision Date 09/13/2019
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
Recalls CDRH Recalls
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