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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Rectal For Continent Ileostomy
510(k) Number K813494
Device Name WATERS ILEAL RESERVOIR CATHETER
Applicant
Waters Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Waters Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5030
Classification Product Code
KPH  
Date Received12/14/1981
Decision Date 12/31/1981
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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