Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K914401 |
Device Name |
UNIVERSAL GENERAL USE KIT #7-510-16 |
Applicant |
NORTHGATE TECHNOLOGIES, INC. |
3930 VENTURA DR. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Applicant Contact |
PETER A MANZIE |
Correspondent |
NORTHGATE TECHNOLOGIES, INC. |
3930 VENTURA DR. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Correspondent Contact |
PETER A MANZIE |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 10/02/1991 |
Decision Date | 11/27/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|