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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K871965
Device Name JMS NEEDLES AND JMS SYRINGES
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 Number880.5860
Classification Product Code
FMF  
Date Received05/19/1987
Decision Date 09/04/1987
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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