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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
510(k) Number K883057
Device Name COMFORT CATH MALE EXTERNAL CATHETER
Applicant
Sierra Laboratories, Inc.
3520 S. Campbell Ave.
P.O. Box 27005
Tucson,  AZ  85726
Applicant Contact KLUG, PHD
Correspondent
Sierra Laboratories, Inc.
3520 S. Campbell Ave.
P.O. Box 27005
Tucson,  AZ  85726
Correspondent Contact KLUG, PHD
Regulation Number876.5250
Classification Product Code
EYT  
Date Received07/19/1988
Decision Date 08/02/1988
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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