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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 K190485
Device Name Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
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. (RCA)
10411 Corporate Drive, Suite 102
Pleasant Prairie,  WI  53158
Correspondent Contact Lisa L. Michels
Regulation Number862.1675
Classification Product Code
JKA  
Date Received02/27/2019
Decision Date 07/08/2019
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
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