Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K003802 |
Device Name |
HYSTEROSCOPES |
Applicant |
GLOBAL ENDOSCOPY, INC. |
914 W. ESTES CT. |
SCHAUMBURG,
IL
60193 -4426
|
|
Applicant Contact |
NICK MIRCEA |
Correspondent |
GLOBAL ENDOSCOPY, INC. |
914 W. ESTES CT. |
SCHAUMBURG,
IL
60193 -4426
|
|
Correspondent Contact |
NICK MIRCEA |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 12/08/2000 |
Decision Date | 07/22/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|