MF SAFECATH

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

MediFirst Co., Ltd.

The following data is part of a premarket notification filed by Medifirst Co., Ltd. with the FDA for Mf Safecath.

Pre-market Notification Details

Device IDK192230
510k NumberK192230
Device Name:MF SAFECATH
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant MediFirst Co., Ltd. #1049-16, Charyeonggogae-ro, Gwangdeok-myeon, Dongnam-gu Cheonan-si,  KR 31223
ContactHa Tae Joo
CorrespondentSanglok Lee
Wise Company Inc. #303, 142, Gasan Digital 1-ro Geumcheon-gu,  KR 08301
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-16
Decision Date2020-04-23

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