ANCHORAGE ACCESS KIT


Device Classification Name

endoscope and/or accessories

510(k) Number K073507
Device Name ANCHORAGE ACCESS KIT
Applicant
EPITEK, INC.
4801 w. 81st street
suite 105
bloomington, 
MN 
55437

Applicant Contact werner hampl
Correspondent
EPITEK, INC.
4801 w. 81st street
suite 105
bloomington, 
MN 
55437

Correspodent Contact werner hampl
Regulation Number 876.1500
Classification Product Code
KOG  
Date Received 12/13/2007
Decision Date 03/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No