HORIZONS CYTOLOGY BRUSH


Device Classification Name

endoscopic cytology brush

510(k) Number K021998
Device Name HORIZONS CYTOLOGY BRUSH
Original Applicant
HORIZONS INTL. CORP.
p.o. box 7273
ponce, 
PR 
00732 -7273

Original Contact rafic saleh
Regulation Number 876.1500
Classification Product Code
FDX  
Date Received 06/19/2002
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