Device Classification Name |
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
More FDA Info for this Device |
510(K) Number |
K192230 |
Device Name |
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days |
Applicant |
MediFirst Co., Ltd.
#1049-16, Charyeonggogae-ro, Gwangdeok-myeon, Dongnam-gu
Cheonan-si 31223 KR
Other 510(k) Applications for this Company
|
Contact |
Ha Tae Joo
Other 510(k) Applications for this Contact |
Regulation Number |
880.5200
More FDA Info for this Regulation Number |
Classification Product Code |
FOZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
08/16/2019 |
Decision Date |
04/23/2020 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
HO - General Hospital |
Review Advisory Committee |
HO - General Hospital |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|