FDA 510(k) Application Details - K023688

Device Classification Name Spatula, Surgical, General & Plastic Surgery

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510(K) Number K023688
Device Name Spatula, Surgical, General & Plastic Surgery
Applicant LEMAITRE VASCULAR, INC.
26 RAY AVE.
BURLINGTON, MA 01803 US
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Contact JAMES ASHBY
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Regulation Number 878.4800

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Classification Product Code GAF
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Date Received 11/01/2002
Decision Date 01/30/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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