The following data is part of a premarket notification filed by Cooper Vision, Inc. with the FDA for Proclear Compatibles Multifocal.
Device ID | K032873 |
510k Number | K032873 |
Device Name: | PROCLEAR COMPATIBLES MULTIFOCAL |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | COOPER VISION, INC. 1215 BOISSEVAIN AVE. Norfolk, VA 23507 |
Contact | Lisa Hahn |
Correspondent | Lisa Hahn COOPER VISION, INC. 1215 BOISSEVAIN AVE. Norfolk, VA 23507 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-15 |
Decision Date | 2003-11-07 |
Summary: | summary |