FDA 510(k) Application Details - K982015

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K982015
Device Name Vinyl Patient Examination Glove
Applicant TAIAN PLASTICS PRODUCTS (JINGXING) CO., LTD.
THE NORTH OF BEISHIMEN VILLAGE
XIAO ZUO TOWN, JINGXING COUNTY
SHIJIAZHUANG CITY, HEBEI PROV. 050306 CN
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Contact MR.LIN CHIN-YU
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 06/08/1998
Decision Date 08/03/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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