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 |