FDA 510(k) Application Details - K110697

Device Classification Name Syringe, Piston

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510(K) Number K110697
Device Name Syringe, Piston
Applicant TIGER MEDICAL PRODUCTS LTD
1 HUAIHAI ZHONG ROAD
LIU LIN TOWER, SUITE 1910
SHANGHAI 200021 CN
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Contact DAVID WANG
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 03/14/2011
Decision Date 07/14/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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