Device Classification Name |
pump, breast, powered
|
510(k) Number |
K150476 |
Device Name |
Spectra S1Plus and Spectra S2 Plus |
Applicant |
UZINMEDICARE CO. |
Rm 105, Joongang Induspia V, Sagimakgolo 137 |
Jungwon-gu,
KR
462-807
|
|
Applicant Contact |
Ho Jun Kang |
Correspondent |
Onbix Corporation |
700 Thirteenth Street, N.W. |
Suite 1200 |
Washington,
DC
20005
|
|
Correspondent Contact |
Charlene Cho |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 02/24/2015 |
Decision Date | 04/15/2016 |
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
|
|
|