The following data is part of a premarket notification filed by A2j, Inc. with the FDA for A2j Mz 45 Laser Light For Positioning.
| Device ID | K881591 |
| 510k Number | K881591 |
| Device Name: | A2J MZ 45 LASER LIGHT FOR POSITIONING |
| Classification | Barrier, Control Panel, X-ray, Movable |
| Applicant | A2J, INC. 10500 RICHMOND SUITE 201 Houston, TX 77042 |
| Contact | Zimmer |
| Correspondent | Zimmer A2J, INC. 10500 RICHMOND SUITE 201 Houston, TX 77042 |
| Product Code | IWX |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-13 |
| Decision Date | 1988-04-27 |