FDA 510(k) Application Details - K031280

Device Classification Name Instrument, Surgical, Sonic And Accessory/Attachment

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510(K) Number K031280
Device Name Instrument, Surgical, Sonic And Accessory/Attachment
Applicant BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW, IN 46581-0587 US
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Contact PATRICIA SANDBORN BERES
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Regulation Number 888.4580

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Classification Product Code JDX
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Date Received 04/22/2003
Decision Date 09/22/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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