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FDA 510(k) Application Details - K032908
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K032908
Device Name
Vinyl Patient Examination Glove
Applicant
SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD.
RM. 707, AVIC BLDG., NO.2
DONG SAN HUAN NAN ROAD
CHAOYANG DISTRICT; BEIJING 100022 CN
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Contact
CHEN YUHONG
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/17/2003
Decision Date
11/20/2003
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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