The following data is part of a premarket notification filed by Pro Design Intl. As with the FDA for Spectable Frame Magnifying Brillette.
| Device ID | K844657 |
| 510k Number | K844657 |
| Device Name: | SPECTABLE FRAME MAGNIFYING BRILLETTE |
| Classification | Screen, Tangent, Target |
| Applicant | PRO DESIGN INTL. AS 20 WATERSIDE PLAZA APT 31-D New York, NY 10010 |
| Contact | Lars Klitbo |
| Correspondent | Lars Klitbo PRO DESIGN INTL. AS 20 WATERSIDE PLAZA APT 31-D New York, NY 10010 |
| Product Code | HOJ |
| CFR Regulation Number | 886.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-29 |
| Decision Date | 1984-12-11 |