FDA 510(k) Application Details - K172397

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

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510(K) Number K172397
Device Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant C.R. Bard, Inc.
605 North 5600 West
Salt Lake City, UT 84116 US
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Contact Mona Shahrebani
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Regulation Number 880.5970

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Classification Product Code LJS
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Date Received 08/08/2017
Decision Date 09/29/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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