FDA 510(k) Application Details - K051156

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K051156
Device Name Vinyl Patient Examination Glove
Applicant SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO.,
RM 1606, BLDG 1 JIANXIANG YUAN
NO 209 BIE SI HUAN ZHONG ROAD
HAIDIAN DISTRICT, BEIJING 100083 CN
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Contact CHU XIAOAN
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 05/04/2005
Decision Date 06/14/2005
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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