FDA 510(k) Application Details - K072562

Device Classification Name Plate, Fixation, Bone

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510(K) Number K072562
Device Name Plate, Fixation, Bone
Applicant MICROWARE PRECISION CO., LTD.
NO. 12 KEYUAN 2ND RD.
SITUN DISTRICT
TAICHUNG CITY 40763 TW
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Contact HARRISON DU
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 09/11/2007
Decision Date 12/04/2008
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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