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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K873288
Device Name CLOSED FOLEY CATHETER SYSTEM
Applicant
Todd Medical, Inc.
4701 W. Schroeder Dr. Suite
170
Brown Deer,  WI  53223
Applicant Contact ROBERT WALTERS
Correspondent
Todd Medical, Inc.
4701 W. Schroeder Dr. Suite
170
Brown Deer,  WI  53223
Correspondent Contact ROBERT WALTERS
Regulation Number876.5130
Classification Product Code
KNY  
Date Received08/17/1987
Decision Date 11/27/1987
Decision Substantially Equivalent - With Drug (SESD)
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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