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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 K163646
Device Name Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator
Applicant
Terragene SA
Guemes 2879
Rosario,  AR 2000
Applicant Contact Maria Victoria Quiroga
Correspondent
Licensale Inc
68 Southwoods Ter
Southbury,  CT  06488
Correspondent Contact Raymond Kelly
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/23/2016
Decision Date 11/02/2017
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
Recalls CDRH Recalls
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