Device Classification Name |
Cup, Menstrual
|
510(k) Number |
K092985 |
Device Name |
BELLECUP |
Applicant |
LIBRETTE, INC |
1705. S. CAPITAL OF TEXAS HWY |
SUITE 500 |
AUSTIN,
TX
78746
|
|
Applicant Contact |
NEAL KOLBER |
Correspondent |
LIBRETTE, INC |
1705. S. CAPITAL OF TEXAS HWY |
SUITE 500 |
AUSTIN,
TX
78746
|
|
Correspondent Contact |
NEAL KOLBER |
Regulation Number | 884.5400
|
Classification Product Code |
|
Date Received | 09/28/2009 |
Decision Date | 06/28/2010 |
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
|
|
|