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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Catheter, Ureteral
510(k) Number K915751
Device Name URETEROMAT 4400
Applicant
F.M. Wiest USA, Inc.
690 Kinderkamack Rd., 1st Floor
P.O. Box 637
Oradell,  NJ  07649
Applicant Contact GEORGE R BATCHELOR
Correspondent
F.M. Wiest USA, Inc.
690 Kinderkamack Rd., 1st Floor
P.O. Box 637
Oradell,  NJ  07649
Correspondent Contact GEORGE R BATCHELOR
Regulation Number876.5470
Classification Product Code
EZN  
Date Received12/23/1991
Decision Date 04/24/1992
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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