• 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 prosthesis, tracheal, expandable
510(k) Number K201342
Device Name HANAROSTENT Trachea/Bronchium (CCC)
M.I. Tech Co., Ltd.
174, Habuk 2-gil, Jinwi-myeon
Pyeongtaek-si,  KR 17706
Applicant Contact Inae Kim
400 Highway 169 South, Suite 500
Minneapolis,  MN  55426
Correspondent Contact Beryl St. Jeanne
Regulation Number878.3720
Classification Product Code
Date Received05/20/2020
Decision Date 12/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No