The following data is part of a premarket notification filed by Criss Optical Mfg. Co., Inc. with the FDA for Mag-1 Spectacle Frame.
| Device ID | K945342 |
| 510k Number | K945342 |
| Device Name: | MAG-1 SPECTACLE FRAME |
| Classification | Frame, Spectacle |
| Applicant | CRISS OPTICAL MFG. CO., INC. 3628 SOUTH WEST ST. P.O. BOX 12267 Wichita, KS 67217 |
| Contact | Diane J Loveall |
| Correspondent | Diane J Loveall CRISS OPTICAL MFG. CO., INC. 3628 SOUTH WEST ST. P.O. BOX 12267 Wichita, KS 67217 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-01 |
| Decision Date | 1994-11-28 |