The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Dual Top Screw System.
Device ID | K161335 |
510k Number | K161335 |
Device Name: | Dual Top Screw System |
Classification | Implant, Endosseous, Orthodontic |
Applicant | JEIL MEDICAL CORPORATION 702, 703, 704, 705, 706, 804, 805, 807, 812-HO, 55, DIGITAL-RO34-GIL, GURO-GU Seoul, KR 08378 |
Contact | Seungyoung Lee |
Correspondent | Seungyoung Lee JEIL MEDICAL CORPORATION 702, 703, 704, 705, 706, 804, 805, 807, 812-HO, 55, DIGITAL-RO34-GIL, GURO-GU Seoul, KR 08378 |
Product Code | OAT |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-05-12 |
Decision Date | 2017-02-23 |
Summary: | summary |