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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 K200272
Device Name Terragene Chemdye
Applicant
Terragene S.A.
Ruta Nacional # 9, Km 280, Parque Industrial Micropi
Alvear,  AR 2130
Applicant Contact Maria Victoria Rocha
Correspondent
Licensale, Inc.
3422 Leonard Ln.
New Smyrna Beach,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received02/04/2020
Decision Date 06/30/2020
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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