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FDA 510(k) Application Details - K032071
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K032071
Device Name
Vinyl Patient Examination Glove
Applicant
SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.
30798 US HWY. 19N
PALM HARBOR, FL 34684 US
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Contact
WILLIAM E HARRIS
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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
07/03/2003
Decision Date
10/10/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
Y
Expedited Review
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