The following data is part of a premarket notification filed by Benz Research And Development Corp. with the FDA for (lenses)benz Hefilcon A Spherical/toric Soft (hydrophilic) Contact Lenses In Clear And With A Blue Or Light Green Visibi.
| Device ID | K972807 |
| 510k Number | K972807 |
| Device Name: | (LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BENZ RESEARCH AND DEVELOPMENT CORP. 6447 PARKLAND DR. Sarasota, FL 34243 |
| Contact | Patrick H Benz |
| Correspondent | Patrick H Benz 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 | 1997-07-28 |
| Decision Date | 1997-10-15 |