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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 K042110
Device Name BEAMCATH
Applicant
BEAMPOINT AB
6740 RIVERVIEW TERRACE
MINNEAPOLIS,  MN  55432
Applicant Contact CONSTANCE BUNDY
Correspondent
BEAMPOINT AB
6740 RIVERVIEW TERRACE
MINNEAPOLIS,  MN  55432
Correspondent Contact CONSTANCE BUNDY
Regulation Number876.5130
Classification Product Code
EZL  
Date Received08/05/2004
Decision Date 02/25/2005
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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