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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Cytology Brush
510(k) Number K912407
Device Name COX DISPOSABLE CYTOLOGY BRUSHES
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
FDX  
Date Received05/30/1991
Decision Date 09/10/1991
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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