The following data is part of a premarket notification filed by Nissel Ltd. with the FDA for S-38 (polymacon) Soft (hydrophilic) Contact Lens, The Esstech Ps & Sv (polymacon) Soft (hydrophilic) Contact Lens.
| Device ID | K990281 |
| 510k Number | K990281 |
| Device Name: | S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | NISSEL LTD. 203 NORTH WABASH AVE. SUITE 1200 Chicago, IL 60601 |
| Contact | John M Szabocsik |
| Correspondent | John M Szabocsik NISSEL LTD. 203 NORTH WABASH AVE. SUITE 1200 Chicago, IL 60601 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-28 |
| Decision Date | 1999-04-16 |
| Summary: | summary |