The following data is part of a premarket notification filed by Ov World Co., Ltd with the FDA for Omega Vl.
Device ID | K162366 |
510k Number | K162366 |
Device Name: | Omega VL |
Classification | Suture, 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 |
Contact | Geung-gyu Gang |
Correspondent | Ho Dong Yang ONBIX CORPORATION #821 SAMIL PLAZA, 837 -26 YEUKSAM-DONG Gangnam-gu, KR 135-768 |
Product Code | NEW |
CFR Regulation Number | 878.4840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-08-23 |
Decision Date | 2018-03-02 |
Summary: | summary |