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FDA 510(k) Application Details - K061756
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K061756
Device Name
Polymer Patient Examination Glove
Applicant
SHEN WEI (USA), INC.
33278 CENTRAL AVE.,
SUITE 102
UNION CITY, CA 94587 US
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Contact
CYNTHIA LIU
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
06/21/2006
Decision Date
04/19/2007
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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