Device Classification Name |
perineometer
|
510(k) Number |
K122800 |
Device Name |
INNER PEACE |
Applicant |
KAMABRY, INC., DBA INNER PEACE FOR WOMEN |
1468 HARWELL HAVE |
CROFTON,
MD
21114
|
|
Applicant Contact |
YOLANDA SMITH |
Correspondent |
KAMABRY, INC., DBA INNER PEACE FOR WOMEN |
1468 HARWELL HAVE |
CROFTON,
MD
21114
|
|
Correspondent Contact |
YOLANDA SMITH |
Regulation Number | 884.1425
|
Classification Product Code |
|
Date Received | 09/12/2012 |
Decision Date | 10/04/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|