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FDA 510(k) Application Details - K140053
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K140053
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD
503 ROOM, 8 BUILDING, 600 LIU ZHOU ROAD
SHANGHAI 200233 CN
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Contact
ALICE GONG
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNH
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More FDA Info for this Product Code
Date Received
01/09/2014
Decision Date
06/26/2014
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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