FDA 510(k) Application Details - K110355

Device Classification Name Stylet, Surgical, General & Plastic Surgery

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510(K) Number K110355
Device Name Stylet, Surgical, General & Plastic Surgery
Applicant VENX LLC
4700 S. OVERLAND DRIVE
TUCSON', AZ 85714 US
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Contact IRA DUESLER
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Regulation Number 878.4800

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Classification Product Code GAH
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Date Received 02/07/2011
Decision Date 04/22/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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