The following data is part of a premarket notification filed by Biocompatibles Eyewear, Inc. with the FDA for Proclear Compatibles Daily Wear Contact Lens.
Device ID | K970095 |
510k Number | K970095 |
Device Name: | PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | BIOCOMPATIBLES EYEWEAR, INC. 1215 BOISSEVAIN AVE. Norfolk, VA 23507 |
Contact | Shirley Mcgarvey |
Correspondent | Shirley Mcgarvey BIOCOMPATIBLES EYEWEAR, 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 | 1997-01-10 |
Decision Date | 1997-04-03 |