Device Classification Name |
cup, menstrual
|
510(k) Number |
K091754 |
Device Name |
LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 |
Applicant |
LUNE GROUP LTD. |
1920 ARLINGTON PLACE |
MADISON,
WI
53726
|
|
Applicant Contact |
MORRIS WAXLER |
Correspondent |
LUNE GROUP LTD. |
1920 ARLINGTON PLACE |
MADISON,
WI
53726
|
|
Correspondent Contact |
MORRIS WAXLER |
Regulation Number | 884.5400
|
Classification Product Code |
|
Date Received | 06/16/2009 |
Decision Date | 11/13/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|