Device Classification Name |
Curette, Uterine
|
510(k) Number |
K850068 |
Device Name |
LUNE AU CURETTES |
Applicant |
LUNEAU LABORATORIES |
2000 L. ST. NW |
SUITE 715 |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
CHAMBORD |
Correspondent |
LUNEAU LABORATORIES |
2000 L. ST. NW |
SUITE 715 |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
CHAMBORD |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 01/08/1985 |
Decision Date | 04/08/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|