CONCENTRIC BALLOON GOOGLE


Device Classification Name

endoscope and/or accessories

510(k) Number K112698
Device Name CONCENTRIC BALLOON GOOGLE
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
KOG  
Subsequent Product Code
ODC  
Date Received 09/16/2011
Decision Date 05/18/2012
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