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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 K931156
Device Name CONE CATH
Applicant
Sierra Laboratories, Inc.
3520 S. Campbell Ave.
P.O. Box 27005
Tucson,  AZ  85726
Applicant Contact PAUL W POLASKO
Correspondent
Sierra Laboratories, Inc.
3520 S. Campbell Ave.
P.O. Box 27005
Tucson,  AZ  85726
Correspondent Contact PAUL W POLASKO
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received03/09/1993
Decision Date 07/01/1993
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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