HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH


Device Classification Name

laparoscope, gynecologic (and accessories)

510(k) Number K080948
Device Name HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley, 
PA 
18034 -0610

Applicant Contact laura storms-tyler
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley, 
PA 
18034 -0610

Correspodent Contact laura storms-tyler
Regulation Number 884.1720
Classification Product Code
HET  
Subsequent Product Codes
GCJ   NWB  
Date Received 04/03/2008
Decision Date 09/26/2008
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