Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K181863 |
Device Name |
Elvie Pump |
Applicant |
Chiaro Technology Limited |
2nd Floor 63-66 Hatton Garden |
London,
GB
EC1N 8LE
|
|
Applicant Contact |
Jonathan O'Toole |
Correspondent |
Contract In-House Counsel and Consultants, LLC (d/b/a FDA At |
53516 Bickett |
Chapel Hill,
NC
27517
|
|
Correspondent Contact |
Marc C. Sanchez |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 07/12/2018 |
Decision Date | 10/10/2018 |
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
|
|
|