FDA 510(k) Application Details - K955175

Device Classification Name Wire, Guide, Catheter

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510(K) Number K955175
Device Name Wire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC.
26351 YNEZ RD.
TEMECULA, CA 92591-4628 US
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Contact JOY TAN
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 11/13/1995
Decision Date 04/05/1996
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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