The following data is part of a premarket notification filed by Gazelle Corp. with the FDA for Plastic Or Glass Magnifier.
| Device ID | K820375 |
| 510k Number | K820375 |
| Device Name: | PLASTIC OR GLASS MAGNIFIER |
| Classification | Magnifier, Hand-held, Low-vision |
| Applicant | GAZELLE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HJF |
| CFR Regulation Number | 886.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-09 |
| Decision Date | 1982-06-14 |