FDA 510(k) Application Details - K143070

Device Classification Name Syringe, Antistick

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510(K) Number K143070
Device Name Syringe, Antistick
Applicant Jiangsu Yile Medical Article Co.,Ltd.
Sanhekou Development Zone
Changzhou City 213115 CN
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Contact Feng Xingyuan
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 10/27/2014
Decision Date 07/07/2015
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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