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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K832165
Device Name IMPROVED SILICATH SILICONE ELASTOMER
Applicant
Travenol Laboratories, S.A.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Travenol Laboratories, S.A.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5130
Classification Product Code
KOD  
Date Received07/05/1983
Decision Date 08/08/1983
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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