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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, For Endoscope
510(k) Number K923672
Device Name COX DISPOSABLE ENDOSCOPE CLEANING BRUSH
Applicant
Cox Medical Ent., Inc.
2186 Eastman Ave., Suite 110
Ventura,  CA  93003
Applicant Contact LANITA COX
Correspondent
Cox Medical Ent., Inc.
2186 Eastman Ave., Suite 110
Ventura,  CA  93003
Correspondent Contact LANITA COX
Regulation Number876.1500
Classification Product Code
FEB  
Date Received07/22/1992
Decision Date 09/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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