FDA 510(k) Application Details - K173017

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K173017
Device Name Vinyl Patient Examination Glove
Applicant Anhui Kindguard Medical Supplies Technology Co.,Ltd
Intersection of Yulan Road and Chayang Road,
Sixian County
Suzhou 234300 CN
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Contact Chen Wei
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 09/27/2017
Decision Date 12/15/2017
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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