Device Classification Name |
pump, breast, powered
|
510(k) Number |
K131153 |
FOIA Releasable 510(k) |
K131153
|
Device Name |
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP |
Applicant |
EVENFLO FEEDING INCORPORATED |
9277 Centre Pointe Dr Ste 160 |
West Chester,
OH
45069
|
|
Applicant Contact |
WADE HALMA |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 04/24/2013 |
Decision Date | 06/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|