FDA 510(k) Application Details - K072739

Device Classification Name Syringe, Antistick

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510(K) Number K072739
Device Name Syringe, Antistick
Applicant SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
SUITE 8D, NO.19, LANE 999
ZHONGSHAN NO.2 ROAD(S)
SHANGHAI 200030 CN
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Contact Diana Hong
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 09/27/2007
Decision Date 03/21/2008
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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