FDA 510(k) Application Details - K051672

Device Classification Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

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510(K) Number K051672
Device Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant BARD ACCESS SYSTEMS, INC.
5425 WEST AMELIA EARNHART DR.
SALT LAKE CITY, UT 84116 US
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Contact LYNN M KIRCHOFF
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Regulation Number 880.5970

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Classification Product Code LJS
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Date Received 06/23/2005
Decision Date 11/23/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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