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 |