FDA 510(k) Application Details - K032411

Device Classification Name Wire, Guide, Catheter

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510(K) Number K032411
Device Name Wire, Guide, Catheter
Applicant JS VASCULAR, INC.
8 SNOWBERRY COURT
ORINDA, CA 94563 US
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Contact MICHAEL A DANIEL
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 08/05/2003
Decision Date 10/07/2003
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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