Device Classification Name |
Cup, Menstrual
|
510(k) Number |
K112165 |
Device Name |
RHEA CUP |
Applicant |
APEX MEDICAL TECHNOLOGIES, INC. |
10064 MESA RIDGE CT., #202 |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
SCOTT HERRICK |
Correspondent |
APEX MEDICAL TECHNOLOGIES, INC. |
10064 MESA RIDGE CT., #202 |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
SCOTT HERRICK |
Regulation Number | 884.5400
|
Classification Product Code |
|
Date Received | 07/28/2011 |
Decision Date | 05/24/2012 |
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
|
|
|