| Device Classification Name |
Cup, Menstrual
|
|---|
| 510(k) Number |
K140626 |
|---|
| Device Name |
MELUNA CLASSIC/SPORT MENSTRUAL CUP |
|---|
| Applicant |
| Meluna |
| 1468 Harwell Ave., |
|
Crofton,
MD
21114
|
|
| Applicant Contact |
YOLANDA SMITH |
| Correspondent |
| Meluna |
| 1468 Harwell Ave., |
|
Crofton,
MD
21114
|
|
| Correspondent Contact |
YOLANDA SMITH |
| Regulation Number | 884.5400 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/11/2014 |
|---|
| Decision Date | 07/10/2014 |
|---|
| 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
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|