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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cystometer, electrical recording
510(k) Number K920574
Device Name CAMSYS 6300
Applicant
F.M. WIEST USA, INC.
690 KINDERKAMACK RD., 1ST FL.
P.O. BOX 637
ORADELL,  NJ  07649
Applicant Contact GEORGE BATCHELOR
Correspondent
F.M. WIEST USA, INC.
690 KINDERKAMACK RD., 1ST FL.
P.O. BOX 637
ORADELL,  NJ  07649
Correspondent Contact GEORGE BATCHELOR
Regulation Number876.1620
Classification Product Code
EXQ  
Date Received02/07/1992
Decision Date 02/17/1993
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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