Device Classification Name |
perineometer
|
510(k) Number |
K121902 |
Device Name |
NATRATONE |
Applicant |
ORELLE CORPORATION LTD |
4739 - 44TH AVE S.W., UNIT 403 |
SEATTLE,
WA
98116
|
|
Applicant Contact |
PATRICIA COOMBES |
Correspondent |
ORELLE CORPORATION LTD |
4739 - 44TH AVE S.W., UNIT 403 |
SEATTLE,
WA
98116
|
|
Correspondent Contact |
PATRICIA COOMBES |
Regulation Number | 884.1425
|
Classification Product Code |
|
Date Received | 06/29/2012 |
Decision Date | 06/06/2013 |
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
|
|
|