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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 K920575
Device Name MERKUR 4000
Applicant
F.M. Wiest USA, Inc.
690 Kinderkamack Rd., 1st Floor
P.O. Box 637
Oradell,  NJ  07649
Applicant Contact GEORGE BATHELOR
Correspondent
F.M. Wiest USA, Inc.
690 Kinderkamack Rd., 1st Floor
P.O. Box 637
Oradell,  NJ  07649
Correspondent Contact GEORGE BATHELOR
Regulation Number876.1620
Classification Product Code
FAP  
Date Received02/07/1992
Decision Date 07/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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