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FDA 510(k) Application Details - K123488
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K123488
Device Name
Polymer Patient Examination Glove
Applicant
PUYANG LINSHI HEALTH CO., LTD
17800 CASTLETON ST.
SUITE 328
CITY OF INDUSTRY, CA 91748 US
Other 510(k) Applications for this Company
Contact
LAURA WENG
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/13/2012
Decision Date
02/08/2013
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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