ANCHORAGE SCOPE, MODEL 000003


Device Classification Name

cystourethroscope

510(k) Number K080780
Device Name ANCHORAGE SCOPE, MODEL 000003
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
FBO  
Date Received 03/19/2008
Decision Date 07/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No