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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K230408
Device Name K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
Applicant
Sb-Kawasumi Laboratories, Inc.
3-15-4 Tonomachi, Kawasaki-Ku, Kawasaki-Shi,
Kanagawa,  JP 210-8602
Applicant Contact Shiro Agehama
Correspondent
Regulatory Compliance Associates, Inc. (Rca)
10411 Corporate Dr.
Suite 102
Pleasant Prarie,  WI  53158
Correspondent Contact Valerie Followell
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FMI  
Date Received02/15/2023
Decision Date 06/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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