The following data is part of a premarket notification filed by Unilens Corp., Usa with the FDA for Simulvue 38 (polymacon) Soft (hydrophilic) Bifocal Contact Lens.
| Device ID | K942372 |
| 510k Number | K942372 |
| Device Name: | SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | UNILENS CORP., USA 10431 72ND ST. NORTH P.O. BOX 2530 Largo, FL 34647 |
| Contact | Josepha Bruno |
| Correspondent | Josepha Bruno UNILENS CORP., USA 10431 72ND ST. NORTH P.O. BOX 2530 Largo, FL 34647 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-18 |
| Decision Date | 1994-07-07 |