FDA 510(k) Application Details - K980723

Device Classification Name Valvulotome

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510(K) Number K980723
Device Name Valvulotome
Applicant VASCUTECH, INC.
164 MIDDLESEX TURNPIKE
BURLINGTON, MA 01803 US
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Contact GEORGE W LEMAITRE
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Regulation Number 870.4885

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Classification Product Code MGZ
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Date Received 02/24/1998
Decision Date 02/12/1999
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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