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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 K883886
Device Name DOUBLE CLOSED URINARY DRAINAGE SYSTEM
Applicant
Knight Medical, Inc.
18120 Ammi Trl.
Houston,  TX  77060
Applicant Contact KENNETH E CLARY
Correspondent
Knight Medical, Inc.
18120 Ammi Trl.
Houston,  TX  77060
Correspondent Contact KENNETH E CLARY
Regulation Number876.5250
Classification Product Code
FCN  
Date Received09/13/1988
Decision Date 12/19/1988
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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