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 K192728
Device Name Agnes
Applicant
Agnes Medical Co., Ltd.
(Seohyeon-Dong, 5fcocoplaza), 20, Seohyeon-Ro 210beon-Gil,
Bundang-Gu
Seongnam-Si,  KR 13591
Applicant Contact SeungHwan Seo
Correspondent
KMC, Inc.
Rm. # 904, 27
Digital-Ro 27ga-Gil, Guro-Gu
Seoul,  KR 08375
Correspondent Contact DongHa Lee
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
KCW  
Date Received09/27/2019
Decision Date 10/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-