FDA 510(k) Application Details - K991407

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

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510(K) Number K991407
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI, PA 19301 US
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Contact SHERI L MUSGNUNG
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Regulation Number 888.3030

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Classification Product Code LXT
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Date Received 04/22/1999
Decision Date 06/11/1999
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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