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FDA 510(k) Application Details - K121811
Device Classification Name
Patient Examination Glove, Specialty
More FDA Info for this Device
510(K) Number
K121811
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
ALBERT 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
06/20/2012
Decision Date
11/21/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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