The following data is part of a premarket notification filed by Nakanishi Optical Products Corp. with the FDA for Metal Fram With Polycarbonate Lens.
| Device ID | K953002 |
| 510k Number | K953002 |
| Device Name: | METAL FRAM WITH POLYCARBONATE LENS |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | NAKANISHI OPTICAL PRODUCTS CORP. NO. 1 OSAKA EKIMAE BLDG., 3-1- 1000, UMED 1-chome, Kita-ku,, JP 530 |
| Contact | Osamu Inoue |
| Correspondent | Osamu Inoue NAKANISHI OPTICAL PRODUCTS CORP. NO. 1 OSAKA EKIMAE BLDG., 3-1- 1000, UMED 1-chome, Kita-ku,, JP 530 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-28 |
| Decision Date | 1995-07-12 |