FDA 510(k) Application Details - K963014

Device Classification Name Filter, Intravascular, Cardiovascular

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510(K) Number K963014
Device Name Filter, Intravascular, Cardiovascular
Applicant NITINOL MEDICAL TECHNOLOGIES, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact SHERRIE COVAL-GOLDSMITH
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Regulation Number 870.3375

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Classification Product Code DTK
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Date Received 08/02/1996
Decision Date 11/18/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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