The following data is part of a premarket notification filed by Gazelle Corp. with the FDA for Magnifying Spectacles W/plastic Lenses.
| Device ID | K844716 |
| 510k Number | K844716 |
| Device Name: | MAGNIFYING SPECTACLES W/PLASTIC LENSES |
| Classification | Spectacle, Magnifying |
| Applicant | GAZELLE CORP. 72-9 JEN AI RD., SEC. 2 Taipei, TW |
| Contact | Paul Huang |
| Correspondent | Paul Huang GAZELLE CORP. 72-9 JEN AI RD., SEC. 2 Taipei, TW |
| Product Code | HOI |
| CFR Regulation Number | 886.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-04 |
| Decision Date | 1985-01-03 |