FDA 510(k) Application Details - K021662

Device Classification Name Screw, Fixation, Bone

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510(K) Number K021662
Device Name Screw, Fixation, Bone
Applicant MAGLY ORTHOPEDICS, LLC
14241 NE WOODINVILLE-DUVALL RD
#415
WOODINVILLE, WA 98072 US
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Contact DAVE STINSON
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 05/20/2002
Decision Date 08/12/2002
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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