The following data is part of a premarket notification filed by Continental Soft Lens, Inc. with the FDA for Continental 45 Toric Soft (hydrophilic) Contact Lenses For Daily Wear.
Device ID | K990011 |
510k Number | K990011 |
Device Name: | CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | CONTINENTAL SOFT LENS, INC. 10 GLENVIEW DR. Littleton, CO 80123 |
Contact | Kim Mcquarrie |
Correspondent | Kim Mcquarrie CONTINENTAL SOFT LENS, INC. 10 GLENVIEW DR. Littleton, CO 80123 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-01-04 |
Decision Date | 1999-05-11 |