Omega VL

Suture, Surgical, Absorbable, Polydioxanone

OV WORLD CO., LTD

The following data is part of a premarket notification filed by Ov World Co., Ltd with the FDA for Omega Vl.

Pre-market Notification Details

Device IDK162366
510k NumberK162366
Device Name:Omega VL
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant OV WORLD CO., LTD (GASAN-DONG, FORMATEC BD)A-202,213 205-28, GASAN DIGITAL 1-R GEUMCHEON-GU Seoul,  KR
ContactGeung-gyu Gang
CorrespondentHo Dong Yang
ONBIX CORPORATION #821 SAMIL PLAZA, 837 -26 YEUKSAM-DONG Gangnam-gu,  KR 135-768
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-23
Decision Date2018-03-02
Summary:summary

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