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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystometric gas (carbon-dioxide) on hydraulic device
510(k) Number K914300
Device Name PHOENIX 5 URODYNAMICS SYSTEM
Applicant
ASPEN MEDICAL LTD.
BRIDGEND RD. INDUSTRIAL ESTATE
DINGWALL, ROSS-SHIRE IV15 9QF
SCOTLAND,  GB
Applicant Contact ROSS K MAXWELL
Correspondent
ASPEN MEDICAL LTD.
BRIDGEND RD. INDUSTRIAL ESTATE
DINGWALL, ROSS-SHIRE IV15 9QF
SCOTLAND,  GB
Correspondent Contact ROSS K MAXWELL
Regulation Number876.1620
Classification Product Code
FAP  
Date Received09/25/1991
Decision Date 06/02/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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