The following data is part of a premarket notification filed by Optical Connection, Inc. with the FDA for S-42 Uv, T-42 Uv Toric And M-42 Uv Multifocal (hefilcon A) Soft (hydrophilic) Contact Lens For Daily Wear.
Device ID | K040900 |
510k Number | K040900 |
Device Name: | S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | OPTICAL CONNECTION, INC. 2091 UPPER SCENIC DRIVE Felton, CA 95018 |
Contact | Garold L Edwards |
Correspondent | Garold L Edwards OPTICAL CONNECTION, INC. 2091 UPPER SCENIC DRIVE Felton, CA 95018 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-06 |
Decision Date | 2004-06-15 |
Summary: | summary |