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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K964757
Device Name CONTIDRAIN CATHETER
Applicant
CONTIMED, INC.
415 VALLEY VIEW TRAIL
HOULTON,  WI  54082
Applicant Contact CLAUDE TIHON
Correspondent
CONTIMED, INC.
415 VALLEY VIEW TRAIL
HOULTON,  WI  54082
Correspondent Contact CLAUDE TIHON
Regulation Number876.5130
Classification Product Code
EZL  
Date Received11/27/1996
Decision Date 06/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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