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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K070143
Device Name JMS PLANECTA STOPCOCK
Applicant
Jms North America Corp.
22320 Foothill Blvd.
Suite 350
Hayward,  CA  94541
Applicant Contact CHONG SWEE CHEAU
Correspondent
Jms North America Corp.
22320 Foothill Blvd.
Suite 350
Hayward,  CA  94541
Correspondent Contact CHONG SWEE CHEAU
Regulation Number880.5440
Classification Product Code
FMG  
Date Received01/16/2007
Decision Date 04/10/2007
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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