The following data is part of a premarket notification filed by Benz Research And Development Corp. with the FDA for Benz-mf (visibility Hangling Tint) (methafilcon A) Soft Daily Wear Contact Lens (lathe-cut).
| Device ID | K003861 |
| 510k Number | K003861 |
| Device Name: | BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BENZ RESEARCH AND DEVELOPMENT CORP. 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing BENZ RESEARCH AND DEVELOPMENT CORP. 623 GLACIER DR. Grand Junction, CO 81503 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-13 |
| Decision Date | 2001-03-08 |