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FDA 510(k) Application Details - K122717
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K122717
Device Name
Mask, Surgical
Applicant
TIGER MEDICAL PRODUCTS LTD
1 HUAIHAI ZHONG ROAD
LIU LIN TOWER, SUITE 1910
SHANGHAI 200021 CN
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Contact
DAVID WANG
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FXX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/05/2012
Decision Date
12/21/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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