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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 K894925
Device Name AMCATH URETERAL DILATORS MODELS 7100,7110,7120
Applicant
Intec Medical, Inc.
175 Connecticut Mills Ave.
Danielson,  CT  06239
Applicant Contact PETER WETTERMANN
Correspondent
Intec Medical, Inc.
175 Connecticut Mills Ave.
Danielson,  CT  06239
Correspondent Contact PETER WETTERMANN
Regulation Number876.5470
Classification Product Code
EZN  
Date Received08/02/1989
Decision Date 12/13/1989
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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