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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, urethral
510(k) Number K063795
Device Name GUARDIANCATHETER-URINARY DRAINAGE CATHETER
Applicant
MARIAN MEDICAL, INC.
319 WESTPORT DR.
LOUISVILLE,  KY  40207
Applicant Contact SANDRA WINKLER
Correspondent
MARIAN MEDICAL, INC.
319 WESTPORT DR.
LOUISVILLE,  KY  40207
Correspondent Contact SANDRA WINKLER
Regulation Number876.5130
Classification Product Code
GBM  
Date Received12/22/2006
Decision Date 03/05/2007
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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