Device Classification Name |
Pump, Breast, Powered
More FDA Info for this Device |
510(K) Number |
K160274 |
Device Name |
Pump, Breast, Powered |
Applicant |
BISTOS CO., LTD.
7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302,
Galmachi-ro, Jungwon-gu
Seongnam 13201 KR
Other 510(k) Applications for this Company
|
Contact |
Jenny Cho
Other 510(k) Applications for this Contact |
Regulation Number |
884.5160
More FDA Info for this Regulation Number |
Classification Product Code |
HGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
02/02/2016 |
Decision Date |
09/01/2016 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OB - Obstetrics/Gynecology |
Review Advisory Committee |
OB - Obstetrics/Gynecology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|