The following data is part of a premarket notification filed by Vericom Co., Ltd. with the FDA for Vonflex Heavy, Vinflex Light.
Device ID | K103164 |
510k Number | K103164 |
Device Name: | VONFLEX HEAVY, VINFLEX LIGHT |
Classification | Material, Impression |
Applicant | VERICOM CO., LTD. #606,5TH DONGYOUNG VENTURESTEL 199-32, ANYANG 7-DONG,MANAN-GU Anyang-si, Gyeonggi-do, KR 430-817 |
Contact | Myung-hwan Oh |
Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-10-27 |
Decision Date | 2010-11-10 |
Summary: | summary |