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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 K223015
Device Name STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
Applicant
Plasmapp Co,., Ltd.
Bvc-111, 125, Gwahak-Ro, Yuseong-Gu
Daejeon,  KR 34141
Applicant Contact Byeong Geon Song
Correspondent
CardioMed Device Consultants, LLC
1783 Forest Dr.
Suite 254
Annapolis,  MD  21401
Correspondent Contact Candace Cederman
Regulation Number880.6860
Classification Product Code
MLR  
Date Received09/29/2022
Decision Date 05/09/2023
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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