The following data is part of a premarket notification filed by Westcon Contact Lens Co., Inc. with the FDA for Horizon/westhin 55-g.
Device ID | K962121 |
510k Number | K962121 |
Device Name: | HORIZON/WESTHIN 55-G |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | WESTCON CONTACT LENS CO., INC. 611 EISENHAUER ST. Grand Junction, CO 81505 |
Contact | Martin Dalsing |
Correspondent | Martin Dalsing WESTCON CONTACT LENS CO., INC. 611 EISENHAUER ST. Grand Junction, CO 81505 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-31 |
Decision Date | 1996-08-26 |