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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 K212193
Device Name Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
Applicant
Plasmapp Co,., Ltd.
Bvc-111, 125, Gwahak-Ro, Yuseong-Gu
Daejeon,  KR 34141
Applicant Contact Seung Hun Lee
Correspondent
CardioMed Device Consultants, LLC
1783 Forest Dr.
Suite 254
Annappolis,  MD  21401
Correspondent Contact Candace Cederman
Regulation Number880.2800
Classification Product Code
FRC  
Subsequent Product Code
JOJ  
Date Received07/14/2021
Decision Date 10/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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