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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Incontinence, Urosheath Type, Sterile
510(k) Number K772144
Device Name CATHETER, DISP., EXTERNAL, MALE
Applicant
Medline Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medline Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received11/15/1977
Decision Date 11/28/1977
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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