FDA 510(k) Application Details - K060403

Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

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510(K) Number K060403
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant MERIDIAN MEDICAL
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact GRACE HOLLAND
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Regulation Number 888.3030

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Classification Product Code LXT
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Date Received 02/15/2006
Decision Date 03/28/2006
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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