The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Aim2.
Device ID | K181011 |
510k Number | K181011 |
Device Name: | AIM2 |
Classification | Material, Impression |
Applicant | GC America Inc. 3737 W. 127th Street Alsip, IL 60803 |
Contact | Mark Heiss |
Correspondent | Mark Heiss GC America Inc. 3737 W. 127th Street Alsip, IL 60803 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-04-17 |
Decision Date | 2018-07-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AIM2 76712859 4416294 Live/Registered |
Syn-Tech Systems, Inc. 2012-11-13 |