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 Elastomer, Silicone Block
510(k) Number K171851
Device Name SOFTXIL
Applicant
Bistool
9, Gwangnaru-Ro 6-Gil
Seongdong-Gu
Seoul,  KR 04796
Applicant Contact Eunhyun Bae
Correspondent
LK Consulting Group USA, Inc.
690 Roosevelt
690 Roosevelt,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number874.3620
Classification Product Code
MIB  
Date Received06/21/2017
Decision Date 03/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-