FDA 510(k) Application Details - K131531

Device Classification Name Syringe, Antistick

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510(K) Number K131531
Device Name Syringe, Antistick
Applicant ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD
NO. 20 SOUTH RENHE ROAD
TIANCHANG CITY, ANHUI PROVINCE 239300 CN
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Contact XIUMING CHONG
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 05/28/2013
Decision Date 05/12/2014
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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