FDA 510(k) Application Details - K990823

Device Classification Name Wire, Guide, Catheter

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510(K) Number K990823
Device Name Wire, Guide, Catheter
Applicant PRECISION VASCULAR SYSTEMS, INC.
360 WAKARA WAY
SALT LAKE CITY, UT 84108 US
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Contact JOHN RAGAZZO
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 03/12/1999
Decision Date 07/23/1999
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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