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FDA 510(k) Application Details - K034060
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K034060
Device Name
Vinyl Patient Examination Glove
Applicant
HONG HUANG TANG INDUSTRIAL CO., LTD.
17A STERLING ROAD
NORTH BILLERICA, MA 01862 US
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Contact
HUAN-CHUNG LI
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
12/31/2003
Decision Date
02/06/2004
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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