FDA 510(k) Application Details - K023668

Device Classification Name Set, Administration, Intravascular

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510(K) Number K023668
Device Name Set, Administration, Intravascular
Applicant JMS NORTH AMERICA CORP.
22320 FOOTHILL BLVD.,
SUITE 350
HAYWARD, CA 94541 US
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Contact SWEE CHEAU CHONG
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 10/31/2002
Decision Date 07/01/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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