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FDA 510(k) Application Details - K101436
Device Classification Name
Patient Examination Glove, Specialty
More FDA Info for this Device
510(K) Number
K101436
Device Name
Patient Examination Glove, Specialty
Applicant
SHEN WEI (USA), INC.
33278 CENTRAL AVE.,
SUITE 102
UNION CITY, CA 94587 US
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Contact
ABLERT LI
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZC
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More FDA Info for this Product Code
Date Received
05/24/2010
Decision Date
11/17/2010
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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