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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinary Drainage Collection Kit, For Indwelling Catheter
510(k) Number K922346
Device Name FEMALE URINE SAMPLING DEVICE
Applicant
Mentor Corp.
5425 Hollister Ave.
Santa Barbara,  CA  93111
Applicant Contact BYRON H WICKETT
Correspondent
Mentor Corp.
5425 Hollister Ave.
Santa Barbara,  CA  93111
Correspondent Contact BYRON H WICKETT
Regulation Number876.5250
Classification Product Code
FCN  
Date Received05/19/1992
Decision Date 08/14/1992
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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