FDA 510(k) Application Details - K141825

Device Classification Name Plate, Fixation, Bone

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510(K) Number K141825
Device Name Plate, Fixation, Bone
Applicant JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT
503 ROOM, 8 BLDG, 600 LIU ZHOU ROAD
SHANGHAI 200233 CN
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Contact ALICE GONG
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 07/07/2014
Decision Date 03/03/2015
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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