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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
510(k) Number K081288
Device Name ASPIRA PERITONEAL DRAINAGE SYSTEM
Applicant
C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY,  UT  84116
Applicant Contact HENRY BOLAND
Correspondent
C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY,  UT  84116
Correspondent Contact HENRY BOLAND
Regulation Number876.5630
Classification Product Code
PNG  
Date Received05/07/2008
Decision Date 07/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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