Device Classification Name |
Insufflator, Hysteroscopic
|
510(k) Number |
K930912 |
Device Name |
HYSTEROMED 100 |
Applicant |
NORTHGATE TECHNOLOGIES, INC. |
3930 VENTURA DR. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Applicant Contact |
KENNETH SIKORA |
Correspondent |
NORTHGATE TECHNOLOGIES, INC. |
3930 VENTURA DR. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Correspondent Contact |
KENNETH SIKORA |
Regulation Number | 884.1700
|
Classification Product Code |
|
Date Received | 02/22/1993 |
Decision Date | 10/17/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|