US ENDOSCOPY CYTOLOGY BRUSH


Device Classification Name

endoscopic cytology brush

510(k) Number K103437
Device Name US ENDOSCOPY CYTOLOGY BRUSH
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley rd.
mentor, 
OH 
44060

Applicant Contact carroll l martin
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley rd.
mentor, 
OH 
44060

Correspodent Contact carroll l martin
Regulation Number 876.1500
Classification Product Code
FDX  
Date Received 11/23/2010
Decision Date 12/23/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls