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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 K021998
Device Name HORIZONS CYTOLOGY BRUSH
Applicant
HORIZONS INTL. CORP.
P.O. BOX 7273
PONCE,  PR  00732 -7273
Applicant Contact RAFIC SALEH
Correspondent
HORIZONS INTL. CORP.
P.O. BOX 7273
PONCE,  PR  00732 -7273
Correspondent Contact RAFIC SALEH
Regulation Number876.1500
Classification Product Code
FDX  
Date Received06/19/2002
Decision Date 07/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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