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FDA 510(k) Application Details - K982257
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K982257
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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CHIN-YU LIN
Other 510(k) Applications for this Contact
Regulation Number
880.6250
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Classification Product Code
LYZ
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More FDA Info for this Product Code
Date Received
06/26/1998
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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