ENDOEYE HD II


Device Classification Name

laparoscope, gynecologic (and accessories)

510(k) Number K111788
Device Name ENDOEYE HD II
Applicant
OLYMPUS AMERICA, INC.
3500 corporate parkway
center valley, 
PA 
18034 -0610

Applicant Contact stacy abbatiello kluesner
Correspondent
OLYMPUS AMERICA, INC.
3500 corporate parkway
center valley, 
PA 
18034 -0610

Correspodent Contact stacy abbatiello kluesner
Regulation Number 884.1720
Classification Product Code
HET  
Date Received 06/24/2011
Decision Date 01/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No