ENDOSCOPIC CO2 REGULATION UNIT UCR


Device Classification Name

laparoscope, gynecologic (and accessories)

510(k) Number K081173
Device Name ENDOSCOPIC CO2 REGULATION UNIT UCR
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  
Date Received 04/24/2008
Decision Date 12/23/2008
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