Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K160511 |
Device Name |
Naya Breast Pump System |
Applicant |
NAYA HEALTH INC. |
390 BRIDGE PKWY |
SUITE C |
Redwood City,
CA
94065
|
|
Applicant Contact |
Janica B. Alvarez |
Correspondent |
NAYA HEALTH INC. |
390 BRIDGE PKWY |
SUITE C |
Redwood City,
CA
94065
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 02/24/2016 |
Decision Date | 06/24/2016 |
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
|
|
|