Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K092770 |
Device Name |
SIMPLYGO HANDS FREE BREAST PUMP |
Applicant |
EVENFLO COMPANY, INC. |
225 BYERS RD. |
MIAMISBURG,
OH
45342
|
|
Applicant Contact |
AMY NEFF |
Correspondent |
EVENFLO COMPANY, INC. |
225 BYERS RD. |
MIAMISBURG,
OH
45342
|
|
Correspondent Contact |
AMY NEFF |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 09/09/2009 |
Decision Date | 10/09/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|