FDA 510(k) Application Details - K030549

Device Classification Name Wire, Guide, Catheter

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510(K) Number K030549
Device Name Wire, Guide, Catheter
Applicant GUIDCORP
26531 YNEZ RD.
TEMECULA, CA 92591 US
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Contact STACEY BROWN
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 02/21/2003
Decision Date 05/14/2003
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

FDA Source Information for K030549


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