FDA 510(k) Application Details - K925947

Device Classification Name Wire, Guide, Catheter

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510(K) Number K925947
Device Name Wire, Guide, Catheter
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES, NJ US
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Contact RUSSELL ARNSBERGER
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 11/24/1992
Decision Date 08/20/1993
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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