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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 K934266
Device Name COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
Applicant
Sierra Laboratories, Inc.
3520 S. Campbell Ave.
Tucson,  AZ  85713
Applicant Contact ROBERT J KLUG, PHD
Correspondent
Sierra Laboratories, Inc.
3520 S. Campbell Ave.
Tucson,  AZ  85713
Correspondent Contact ROBERT J KLUG, PHD
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received08/31/1993
Decision Date 04/19/1994
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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