FDA 510(k) Application Details - K110396

Device Classification Name

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510(K) Number K110396
Device Name ASPIRA PERITONEAL DRAINAGE SYSTEM
Applicant C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY, UT 84116 US
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Contact HENRY BOLAND
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Regulation Number

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Classification Product Code PNG
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Date Received 02/11/2011
Decision Date 05/06/2011
Decision SESE - SUBST EQUIV
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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