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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Uroflowmeter
510(k) Number K880504
Device Name MCT MEDICAL BROWNE UROSCAN URODYNAMIC
Applicant
Mct Medical, Inc.
599 Cardigan Rd.
P.O. Box 64022
Shoreview,  MN  55126
Applicant Contact NANCY J POPP
Correspondent
Mct Medical, Inc.
599 Cardigan Rd.
P.O. Box 64022
Shoreview,  MN  55126
Correspondent Contact NANCY J POPP
Regulation Number876.1800
Classification Product Code
EXY  
Date Received02/05/1988
Decision Date 06/17/1988
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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