ASPIRA PERITONEAL DRAINAGE SYSTEM


Device Classification Name

catheter, peritoneal, 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

Correspodent Contact henry boland
Regulation Number 876.5630
Classification Product Code
FJS  
Date Received 05/07/2008
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