FDA 510(k) Application Details - K060082

Device Classification Name Set, Administration, Intravascular

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510(K) Number K060082
Device Name Set, Administration, Intravascular
Applicant TIANJIN MEDIS INTERNATIONAL TRADE CO., LTD.
WANSHUN GARDEN C 1801
89# HUANGPU NAN ROAD
HEXI DISTRICT, TIANJIN 300201 CN
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Contact CINDY WANG
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 01/10/2006
Decision Date 03/31/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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