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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Coring (Huber) Needle
510(k) Number K252355
Device Name K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
Applicant
Sb-Kawasumi Laboratories, Inc.
3-25-4 Tonomachi, Kawasaki-Ku, Kawasaki-Shi
Kanagawa,  JP 210-8602
Applicant Contact Kenichi Inamura
Correspondent
Regulatory Compliance Associates, Inc. (Rca)
10411 Corporate Dr.
Suite 102
Pleasant Prarie,  WI  53158
Correspondent Contact Valerie Followell
Regulation Number880.5570
Classification Product Code
PTI  
Subsequent Product Code
FPA  
Date Received07/29/2025
Decision Date 11/26/2025
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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