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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 K860571
Device Name F.M. WEIST,KG (URODYNAMIC SYSTEMS)
Applicant
F.M. WIEST USA, INC.
1301 N. KINGS HIGHWAY
CHERRY HILL,  NJ  08034
Applicant Contact WAYNE W DISANZA
Correspondent
F.M. WIEST USA, INC.
1301 N. KINGS HIGHWAY
CHERRY HILL,  NJ  08034
Correspondent Contact WAYNE W DISANZA
Regulation Number876.1620
Classification Product Code
FAP  
Date Received02/14/1986
Decision Date 03/18/1986
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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