The following data is part of a premarket notification filed by Benz Research And Development Corp. with the FDA for (lenses) Benz-g 3x (hioxifilcon B) Spherical And Toric Soft (hydrophilic) Contact Lenses In Clear And With A Blue Tint.
| Device ID | K964528 |
| 510k Number | K964528 |
| Device Name: | (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BENZ RESEARCH AND DEVELOPMENT CORP. 235 NORTH TALBOT CT. Roswell, GA 30076 -1668 |
| Contact | Wally Stirling |
| Correspondent | Wally Stirling BENZ RESEARCH AND DEVELOPMENT CORP. 235 NORTH TALBOT CT. Roswell, GA 30076 -1668 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-12 |
| Decision Date | 1997-03-07 |
| Summary: | summary |