Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K940316 |
Device Name |
HYSTERSCOPE |
Applicant |
STEPHEN CHAKOFF, INC. |
15405 SOUTHWEST 72 CT. |
MIAMI,
FL
33157
|
|
Applicant Contact |
FRANK GOLDFARB |
Correspondent |
STEPHEN CHAKOFF, INC. |
15405 SOUTHWEST 72 CT. |
MIAMI,
FL
33157
|
|
Correspondent Contact |
FRANK GOLDFARB |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 01/24/1994 |
Decision Date | 11/16/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|