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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Suprapubic (And Accessories)
510(k) Number K904434
Device Name SEXTON CYSTOTOMY URINE PUMP (SCUP2)
Applicant
PHOENIX BIOENGINEERING, INC.
THIRD AND MILL STREETS
P.O. BOX 96
BRIDGEPORT,  PA  19405
Applicant Contact WILMER
Correspondent
PHOENIX BIOENGINEERING, INC.
THIRD AND MILL STREETS
P.O. BOX 96
BRIDGEPORT,  PA  19405
Correspondent Contact WILMER
Regulation Number876.5090
Classification Product Code
KOB  
Date Received09/28/1990
Decision Date 02/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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