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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 K962384
Device Name COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
Applicant
Sierra Laboratories, Inc.
3520 S. Campbell Ave.
Tucson,  AZ  85713
Applicant Contact ANNA PEREZ
Correspondent
Sierra Laboratories, Inc.
3520 S. Campbell Ave.
Tucson,  AZ  85713
Correspondent Contact ANNA PEREZ
Regulation Number876.5250
Classification Product Code
EXJ  
Subsequent Product Code
EYT  
Date Received06/20/1996
Decision Date 07/15/1996
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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