Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K921942 |
Device Name |
HYSTEROSCOPE (AND ACCESSORIES) |
Applicant |
OPTIMED TECHNOLOGIES, INC. |
17991 FITCH |
IRVINE,
CA
92714
|
|
Applicant Contact |
RONALD J EHMSEN |
Correspondent |
OPTIMED TECHNOLOGIES, INC. |
17991 FITCH |
IRVINE,
CA
92714
|
|
Correspondent Contact |
RONALD J EHMSEN |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 04/24/1992 |
Decision Date | 06/24/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|