BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP

Cystometric Gas (carbon-dioxide) On Hydraulic Device

BROWNE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Browne Medical Systems, Inc. with the FDA for Browne Medical Syst.inc Stand-alone Water Pump.

Pre-market Notification Details

Device IDK910285
510k NumberK910285
Device Name:BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP
ClassificationCystometric Gas (carbon-dioxide) On Hydraulic Device
Applicant BROWNE MEDICAL SYSTEMS, INC. 8990 SPRINGBROOK DRIVE, SUITE 120 Minneapolis,  MN  55433
ContactDeborah Hall
CorrespondentDeborah Hall
BROWNE MEDICAL SYSTEMS, INC. 8990 SPRINGBROOK DRIVE, SUITE 120 Minneapolis,  MN  55433
Product CodeFAP  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-22
Decision Date1991-04-02

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