FDA 510(k) Application Details - K050964

Device Classification Name Wire, Guide, Catheter

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510(K) Number K050964
Device Name Wire, Guide, Catheter
Applicant BOSTON SCIENTIFIC - PRECISION VASCULAR
2405 WEST ORTON CIR.
WEST VALLEY CITY, UT 84119 US
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Contact RICK GAYKOWSKI
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 04/18/2005
Decision Date 06/13/2005
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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