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FDA 510(k) Application Details - K051683
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K051683
Device Name
Vinyl Patient Examination Glove
Applicant
SHEN WEI (USA), INC.
33278 CENTRAL AVE. #102
UNION CITY, CA 94587 US
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Contact
STANLEY DUAN
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
06/23/2005
Decision Date
08/01/2005
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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