Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K162415 |
Device Name |
Spectra 9Plus |
Applicant |
Uzinmedicare Company |
Room 105, Joongang Induspia V, Sagimakgolo 137 |
Jungwon-gu, Seoungnam-Si |
Seoul,
KR
13202
|
|
Applicant Contact |
Nathan Ahn |
Correspondent |
Hyman, Phelps & McNamara, P.C. |
700 Thirteenth Street, N.W., Suite 1200 |
Washington,
DC
20005
|
|
Correspondent Contact |
Jeffrey K. Shapiro |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 08/29/2016 |
Decision Date | 03/15/2017 |
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
|
|
|