The following data is part of a premarket notification filed by Menicon U.s.a., Inc. with the FDA for Menicon Z Bifocal Design Lens/menicon Z Trifocal Design Lens.
| Device ID | K970019 |
| 510k Number | K970019 |
| Device Name: | MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | MENICON U.S.A., INC. 700 THIRTEEN STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Contact | S. Wes Siegner, Jr. |
| Correspondent | S. Wes Siegner, Jr. MENICON U.S.A., INC. 700 THIRTEEN STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-02 |
| Decision Date | 1997-03-25 |
| Summary: | summary |