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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Accessories, Cleaning Brushes, For Endoscope
510(k) Number K950689
Device Name UCB
Applicant
Cox Medical Ent., Inc.
2186 Eastman Ave., Suite 110
Ventura,  CA  93003
Applicant Contact L ANITA
Correspondent
Cox Medical Ent., Inc.
2186 Eastman Ave., Suite 110
Ventura,  CA  93003
Correspondent Contact L ANITA
Regulation Number876.1500
Classification Product Code
MNL  
Date Received02/14/1995
Decision Date 03/06/1995
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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