Device Classification Name |
Cup, Menstrual
|
510(k) Number |
K040335 |
Device Name |
MOONCUP, STYLE A & B |
Applicant |
MOONCUP LLC |
ONE EAST MAIN STREET |
MADISON,
WI
53701
|
|
Applicant Contact |
MORRIS WAXLER |
Correspondent |
MOONCUP LLC |
ONE EAST MAIN STREET |
MADISON,
WI
53701
|
|
Correspondent Contact |
MORRIS WAXLER |
Regulation Number | 884.5400
|
Classification Product Code |
|
Date Received | 02/11/2004 |
Decision Date | 03/30/2005 |
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
|
|
|