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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 K970966
Device Name COMFORT CATH CHOICE MALE EXTERNAL CATHETER
Applicant
SIERRA LABORATORIES, INC.
3520 SOUTH CAMPBELL AVE.
TUCSON,  AZ  85713
Applicant Contact ANNA PEREZ
Correspondent
SIERRA LABORATORIES, INC.
3520 SOUTH CAMPBELL AVE.
TUCSON,  AZ  85713
Correspondent Contact ANNA PEREZ
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received03/17/1997
Decision Date 04/22/1997
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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