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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
Terragene SA
Ruta Nacional No. 9, Km 280, Parque Industrial Micropi
alvear,  AR 2130
Applicant Contact maria victoria rocha
Licensale Inc
3422 Leonard Ln
new smyrna beach,  FL  32168
Correspondent Contact raymond kelly
Regulation Number880.2800
Classification Product Code
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