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 Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K162366
Device Name Omega VL
Applicant
Ov World Co., Ltd.
(Gasan-Dong, Formatec Bd)A-202,213 205-28, Gasan Digital 1-R
Geumcheon-Gu
Seoul,  KR
Applicant Contact GEUNG-GYU GANG
Correspondent
Onbix Corporation
#821 Samil Plz., 837 -26 Yeuksam-Dong
Gangnam-Gu,  KR 135-768
Correspondent Contact HO DONG YANG
Regulation Number878.4840
Classification Product Code
NEW  
Date Received08/23/2016
Decision Date 03/02/2018
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
Predetermined Change
Control Plan Authorized		 No
-
-