The following data is part of a premarket notification filed by Benz Research And Development Corp. with the FDA for Benz B17 (kolfocon A) Rigid Gas Permeable (hydrophobic Daily Wear Contact Lens (clear And Tinted, Lathe-cut From Lens Bl.
| Device ID | K963512 |
| 510k Number | K963512 |
| Device Name: | BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | BENZ RESEARCH AND DEVELOPMENT CORP. 611 EISENHAUER ST. Grand Junction, CO 81505 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing BENZ RESEARCH AND DEVELOPMENT CORP. 611 EISENHAUER ST. Grand Junction, CO 81505 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1997-07-31 |