FDA 510(k) Application Details - K961777

Device Classification Name Wire, Guide, Catheter

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510(K) Number K961777
Device Name Wire, Guide, Catheter
Applicant CARDIOMETRICS, INC.
645 CLYDE AVE.
MOUNTAIN VIEW, CA 94043 US
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Contact Claire Andrews
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 05/07/1996
Decision Date 07/31/1996
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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