EUS BALLOON


Device Classification Name

colonoscope and accessories, flexible/rigid

510(k) Number K111028
Device Name EUS BALLOON
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
FDF  
Subsequent Product Code
ITX  
Date Received 04/13/2011
Decision Date 11/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No