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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Chemical
510(k) Number K220345
Device Name STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; 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
Annapolis,  MD  21401
Correspondent Contact Candace Cederman
Regulation Number880.6860
Classification Product Code
MLR  
Subsequent Product Codes
FRC   FRG   JOJ  
Date Received02/07/2022
Decision Date 04/14/2023
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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