FDA 510(k) Application Details - K954760

Device Classification Name Catheter, Embolectomy

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510(K) Number K954760
Device Name Catheter, Embolectomy
Applicant LUCAS MEDICAL, INC.
1751 SOUTH DOUGLASS RD.
ANAHEIM, CA 92806 US
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Contact DANIEL LUCAS
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Regulation Number 870.5150

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Classification Product Code DXE
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Date Received 10/17/1995
Decision Date 04/11/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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