Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K121322 |
Device Name |
CLOSER TO NATURE |
Applicant |
MAYBORN GROUP LIMITED |
DUDLEY LANE |
CRAMLINGTON |
NORTHUMBERLAN,
GB
NE23 TRH
|
|
Applicant Contact |
NEIL HEWITT |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 05/02/2012 |
Decision Date | 05/31/2012 |
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
|
|
|