40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0


Device Classification Name

insufflator, laparoscopic

510(k) Number K022052
Device Name 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
Original Applicant
NORTHGATE TECHNOLOGIES, INC.
600 church rd.
elgin, 
IL 
60123

Original Contact casey kurek
Regulation Number 884.1730
Classification Product Code
HIF  
Date Received 06/24/2002
Decision Date 01/24/2003
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