FDA 510(k) Application Details - K033294

Device Classification Name Catheter, Hemodialysis, Implanted

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510(K) Number K033294
Device Name Catheter, Hemodialysis, Implanted
Applicant C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
SALT LAKE CITY, UT 84116 US
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Contact GLENN NORTON
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Regulation Number 876.5540

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Classification Product Code MSD
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Date Received 10/14/2003
Decision Date 11/26/2003
Decision SESK - SUBST EQUIV - KIT
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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