FDA 510(k) Application Details - K091987

Device Classification Name Clip, Implantable

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510(K) Number K091987
Device Name Clip, Implantable
Applicant LEMAITRE VASCULAR, INC.
63 2ND AVENUE
BURLINGTON, MA 01803 US
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Contact ERIN E DALY
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 07/02/2009
Decision Date 04/23/2010
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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