Device Classification Name |
pump, breast, powered
|
510(k) Number |
K210124 |
Device Name |
Synergy Gold (SG) Portable (Models MM011450 and MM011460) |
Applicant |
Uzinmedicare Co. |
56, Dongtansandan 5-Gil,Dongtan-Myeon |
Hwaseong-Si,
KR
18487
|
|
Applicant Contact |
Nathan Ahn |
Correspondent |
Hyman, Phelps, & McNamara, P.C. |
700 Thirteenth Street, N.W., Suite 1200 |
Washington,
DC
20005
|
|
Correspondent Contact |
Adrienne R. Lenz |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 01/19/2021 |
Decision Date | 10/19/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|