FDA 510(k) Application Details - K150224

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K150224
Device Name Vinyl Patient Examination Glove
Applicant ZIBO SANYING TRADE CO., LTD
XILV VILLAGE FANGZHEN, ZHANGDIAN DISTRICT
Zibo 255000 CN
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Contact Jing Li
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 02/02/2015
Decision Date 05/12/2015
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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