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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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