MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215

Device Classification Name

insufflator, laparoscopic

510(k) Number K033614
Device Name MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
Applicant
NORTHGATE TECHNOLOGIES, INC.
600 church rd.
elgin, 
IL 
60123

Applicant Contact casey kurek
Correspondent
NORTHGATE TECHNOLOGIES, INC.
600 church rd.
elgin, 
IL 
60123

Correspodent Contact casey kurek
Regulation Number 884.1730
Classification Product Code
HIF  
Date Received 11/17/2003
Decision Date 07/29/2004
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