FDA 510(k) Application Details - K991646

Device Classification Name Wire, Guide, Catheter

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510(K) Number K991646
Device Name Wire, Guide, Catheter
Applicant CORDIS NEUROVASCULAR, INC.
14000 N.W. 57TH CT.
MIAMI LAKES, FL 33014 US
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Contact MARITZA CELAYA
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 05/13/1999
Decision Date 09/23/1999
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

FDA Source Information for K991646


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