MULTIPLE BIOPSY SYSTEM


Device Classification Name

instrument, biopsy, suction

510(k) Number K103326
Device Name MULTIPLE BIOPSY SYSTEM
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 876.1075
Classification Product Code
FCK  
Date Received 11/12/2010
Decision Date 04/06/2011
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