Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K142168 |
Device Name |
NATURE'S BOND 600 AND NATURE'S BOND 603 |
Applicant |
DEVON MEDICAL PRODUCTS, INC. |
1100 FIRST AVENUE, SUITE 202 |
KING OF PRUSSIA,
PA
19406
|
|
Applicant Contact |
Ruth Wu |
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 | 08/06/2014 |
Decision Date | 12/04/2014 |
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
|
|
|