The following data is part of a premarket notification filed by Universal Massage & Tanning, Inc. with the FDA for Makrolon 2405 Goggles (light And Dark).
| Device ID | K945346 |
| 510k Number | K945346 |
| Device Name: | MAKROLON 2405 GOGGLES (LIGHT AND DARK) |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | UNIVERSAL MASSAGE & TANNING, INC. 1385 EAST OAKLAND PARK RD. Ft. Lauderdale, FL 33334 |
| Contact | Robert Holtman |
| Correspondent | Robert Holtman UNIVERSAL MASSAGE & TANNING, INC. 1385 EAST OAKLAND PARK RD. Ft. Lauderdale, FL 33334 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-02 |
| Decision Date | 1994-11-22 |