FDA 510(k) Application Details - K991723

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

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510(K) Number K991723
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant IMMEDICA, INC.
100 PASSAIC AVE.
CHATHAM, NJ 07928-2848 US
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Contact ROY BOGERT
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Regulation Number 888.3030

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Classification Product Code LXT
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Date Received 05/20/1999
Decision Date 07/22/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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