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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 K023668
Device Name JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR
Applicant
Jms North America Corp.
22320 Foothill Blvd.
Suite 350
Hayward,  CA  94541
Applicant Contact SWEE CHEAU CHONG
Correspondent
Jms North America Corp.
22320 Foothill Blvd.
Suite 350
Hayward,  CA  94541
Correspondent Contact SWEE CHEAU CHONG
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/31/2002
Decision Date 07/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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