The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Gbr System.
| Device ID | K143730 |
| 510k Number | K143730 |
| Device Name: | GBR System |
| Classification | Plate, Bone |
| Applicant | JEIL MEDICAL CORPORATION 702-706, 804, 805,807,812-HO ,55, DIGITAL-RO 34-GIL, GURO-GU Seoul, KR 152-728 |
| Contact | Hyeroung Lee |
| Correspondent | Hyeroung Lee JEIL MEDICAL CORPORATION 702-706, 804, 805,807,812-HO ,55, DIGITAL-RO 34-GIL, GURO-GU Seoul, KR 152-728 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-29 |
| Decision Date | 2015-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809282812088 | K143730 | 000 |
| 08806390801218 | K143730 | 000 |
| 08806390801225 | K143730 | 000 |
| 08806390801232 | K143730 | 000 |
| 08809282812026 | K143730 | 000 |
| 08809282812033 | K143730 | 000 |
| 08809282812040 | K143730 | 000 |
| 08809282812057 | K143730 | 000 |
| 08809282812064 | K143730 | 000 |
| 08809282812071 | K143730 | 000 |
| 08806390801201 | K143730 | 000 |