The following data is part of a premarket notification filed by Benz Research And Development Corp. with the FDA for Benz-g 4x (hioxifilcon D) Multifocal Lathed Lens.
| Device ID | K101122 |
| 510k Number | K101122 |
| Device Name: | BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BENZ RESEARCH AND DEVELOPMENT CORP. 6447 PARKLAND DR. Sarasota, FL 34243 |
| Contact | Giovanny Espinosa |
| Correspondent | Giovanny Espinosa BENZ RESEARCH AND DEVELOPMENT CORP. 6447 PARKLAND DR. Sarasota, FL 34243 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-21 |
| Decision Date | 2010-08-09 |
| Summary: | summary |