Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K192230
Device Name MF SAFECATH
Applicant
MediFirst Co., Ltd.
#1049-16, Charyeonggogae-ro, Gwangdeok-myeon, Dongnam-gu
Cheonan-si,  KR 31223
Applicant Contact Ha Tae Joo
Correspondent
Wise Company Inc.
#303, 142, Gasan digital 1-ro
Geumcheon-gu,  KR 08301
Correspondent Contact Sanglok Lee
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/16/2019
Decision Date 04/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-