The following data is part of a premarket notification filed by Glendale Protective Technologies, Inc. with the FDA for Lasermed* Goggles And Spectacles.
| Device ID | K894835 |
| 510k Number | K894835 |
| Device Name: | LASERMED* GOGGLES AND SPECTACLES |
| Classification | Laser, Ophthalmic |
| Applicant | GLENDALE PROTECTIVE TECHNOLOGIES, INC. 130 CROSSWAYS PARK DR. Woodbury, NY 11797 |
| Contact | Joel G Kaufman |
| Correspondent | Joel G Kaufman GLENDALE PROTECTIVE TECHNOLOGIES, INC. 130 CROSSWAYS PARK DR. Woodbury, NY 11797 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-31 |
| Decision Date | 1989-09-21 |