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 electrosurgical, cutting & coagulation & accessories
510(k) Number K220996
Device Name Duoblade
Applicant
CnC Technologies
E1101, Gwang Myeong Technopark, 60, Haan-Ro
Gwangmyeong-Si,  KR 14322
Applicant Contact InSang Choi
Correspondent
KMC, Inc.
Room no. 1709, 123, Digital-ro 26-gil, Guro-gu
Seoul,  KR 08390
Correspondent Contact WooSeok Jeong
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/04/2022
Decision Date 02/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-