FDA 510(k) Application Details - K021323

Device Classification Name Wire, Guide, Catheter

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510(K) Number K021323
Device Name Wire, Guide, Catheter
Applicant INTRALUMINAL THERAPEUTICS, INC.
6354 CORTE DEL ABETO
SUITE A
CARLSBAD, CA 92009 US
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Contact PAMELA MISAJON
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 04/26/2002
Decision Date 05/22/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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