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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K190233
Device Name K-Shield Advantage Port Access Infusion Set (PAIS)
Applicant
Kawasumi Laboratories, Inc.
Shinagawa Intercity Tower B, 9th Floor
2-15-2, Konan, Minato-Ku
Tokyo,  JP 108-6109
Applicant Contact Katsu Furuya
Correspondent
Regulatory Compliance Associates, Inc.
10411 Corporate Drive, Suite 102
Pleasant Prairie,  WI  53158
Correspondent Contact Valerie Followell
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/06/2019
Decision Date 05/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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