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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 K900770
FOIA Releasable 510(k) K900770
Device Name HOME URODATA SYSTEM(TM)
Applicant
Biodan Medical Systems, Ltd.
P.O.B. 2012
Rehovot 76120
Israel,  IL
Applicant Contact MARC COLES
Correspondent
Biodan Medical Systems, Ltd.
P.O.B. 2012
Rehovot 76120
Israel,  IL
Correspondent Contact MARC COLES
Regulation Number876.1800
Classification Product Code
EXY  
Date Received02/16/1990
Decision Date 06/08/1990
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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