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FDA 510(k) Application Details - K133840
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K133840
Device Name
Plate, Fixation, Bone
Applicant
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD
503 ROOM, 8 BUILDING, 600 LIU ZHOU ROAD
SHANGHAI 200233 CN
Other 510(k) Applications for this Company
Contact
ALICE GONG
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/2013
Decision Date
07/29/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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