The following data is part of a premarket notification filed by Megagen Implant Co., Ltd with the FDA for I-gen.
| Device ID | K131289 |
| 510k Number | K131289 |
| Device Name: | I-GEN |
| Classification | Plate, Bone |
| Applicant | MEGAGEN IMPLANT CO., LTD 325 N PUENTE ST. UNIT B Brea, CA 92821 |
| Contact | April Lee |
| Correspondent | April Lee MEGAGEN IMPLANT CO., LTD 325 N PUENTE ST. UNIT B Brea, CA 92821 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2013-09-25 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() I-GEN 85491832 not registered Dead/Abandoned |
Fearless Industries, LLC 2011-12-09 |
![]() I-GEN 78864726 not registered Dead/Abandoned |
JNL Trading Company LP 2006-04-19 |
![]() I-GEN 77864825 3843054 Dead/Cancelled |
Ginsey Industries, Inc. 2009-11-04 |
![]() I-GEN 77347790 3755239 Dead/Cancelled |
I-GEN HEALTHCARE Ltd. 2007-12-10 |
![]() I-GEN 77233940 3603371 Dead/Cancelled |
I-GEN, LLC 2007-07-19 |