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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Blood Transfusion
510(k) Number K880174
Device Name JMS TRANSFUSION SET
Applicant
JMS CO., LTD.
12-17, KAKO-MACHI, NAKA-KU
HIROSHIMA,  JP 730-8652
Applicant Contact SAKAE OGATA
Correspondent
JMS CO., LTD.
12-17, KAKO-MACHI, NAKA-KU
HIROSHIMA,  JP 730-8652
Correspondent Contact SAKAE OGATA
Regulation Number880.5440
Classification Product Code
BRZ  
Date Received01/15/1988
Decision Date 02/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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