HIGH FLOW INSUFFLATION UNIT UHI-4


Device Classification Name

insufflator, laparoscopic

510(k) Number K110294
Device Name HIGH FLOW INSUFFLATION UNIT UHI-4
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
center valley, 
PA 
18034 -0610

Applicant Contact stacy abbatiello kluesner
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
center valley, 
PA 
18034 -0610

Correspodent Contact stacy abbatiello kluesner
Regulation Number 884.1730
Classification Product Code
HIF  
Subsequent Product Code
OSV  
Date Received 02/01/2011
Decision Date 11/18/2011
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