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.
Device ID | K910285 |
510k Number | K910285 |
Device Name: | BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP |
Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
Applicant | BROWNE MEDICAL SYSTEMS, INC. 8990 SPRINGBROOK DRIVE, SUITE 120 Minneapolis, MN 55433 |
Contact | Deborah Hall |
Correspondent | Deborah Hall BROWNE MEDICAL SYSTEMS, INC. 8990 SPRINGBROOK DRIVE, SUITE 120 Minneapolis, MN 55433 |
Product Code | FAP |
CFR Regulation Number | 876.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-22 |
Decision Date | 1991-04-02 |