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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, urine drainage, closed, for nonindwelling catheter, sterile
510(k) Number K896695
Device Name DYNA-FLO URINARY DRAINAGE BAG
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Applicant Contact IVAN PLACKO
Correspondent
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Correspondent Contact IVAN PLACKO
Regulation Number876.5250
Classification Product Code
EYZ  
Date Received11/28/1989
Decision Date 05/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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