Device Classification Name |
insufflator, hysteroscopic
|
510(k) Number |
K895659 |
Device Name |
HUI MINI-FLEX |
Applicant |
UNIMAR, INC. |
475 DANBURY RD. |
WILTON,
CT
06897
|
|
Applicant Contact |
ANTHONY HEMMING |
Correspondent |
UNIMAR, INC. |
475 DANBURY RD. |
WILTON,
CT
06897
|
|
Correspondent Contact |
ANTHONY HEMMING |
Regulation Number | 884.1700
|
Classification Product Code |
|
Date Received | 09/20/1989 |
Decision Date | 12/19/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|