SEXTON CYSTOTOMY URINE PUMP (SCUP2)

Catheter, Suprapubic (and Accessories)

PHOENIX BIOENGINEERING, INC.

The following data is part of a premarket notification filed by Phoenix Bioengineering, Inc. with the FDA for Sexton Cystotomy Urine Pump (scup2).

Pre-market Notification Details

Device IDK904434
510k NumberK904434
Device Name:SEXTON CYSTOTOMY URINE PUMP (SCUP2)
ClassificationCatheter, Suprapubic (and Accessories)
Applicant PHOENIX BIOENGINEERING, INC. THIRD AND MILL STREETS P.O. BOX 96 Bridgeport,  PA  19405
ContactWilmer
CorrespondentWilmer
PHOENIX BIOENGINEERING, INC. THIRD AND MILL STREETS P.O. BOX 96 Bridgeport,  PA  19405
Product CodeKOB  
CFR Regulation Number876.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-28
Decision Date1991-02-01

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