FDA 510(k) Application Details - K915496

Device Classification Name Wire, Guide, Catheter

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510(K) Number K915496
Device Name Wire, Guide, Catheter
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
9450 SOUTH STATE SREET
SANDY, UT US
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Contact CHARLES WELLE
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 12/09/1991
Decision Date 02/27/1992
Decision SE - Substantially Equivalent
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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