Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K972675 |
Device Name |
CO2 GAS WARMING UNIT (6-800-00) |
Applicant |
NORTHGATE TECHNOLOGIES, INC. |
600 CHURCH RD. |
ELGIN,
IL
60123
|
|
Applicant Contact |
CASEY KUREK |
Correspondent |
NORTHGATE TECHNOLOGIES, INC. |
600 CHURCH RD. |
ELGIN,
IL
60123
|
|
Correspondent Contact |
CASEY KUREK |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 07/16/1997 |
Decision Date | 09/30/1998 |
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
|
|
|