The following data is part of a premarket notification filed by Biocompatibles Ltd. with the FDA for Proclear Daily Wear Contact Lens.
Device ID | K952152 |
510k Number | K952152 |
Device Name: | PROCLEAR DAILY WEAR CONTACT LENS |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | BIOCOMPATIBLES LTD. BRUNEL SCIENCE PARK KINGSTON LANE UXBRIDGE Middlesex, England, GB Ub8 3pq |
Contact | Neil Mclachlan |
Correspondent | Neil Mclachlan BIOCOMPATIBLES LTD. BRUNEL SCIENCE PARK KINGSTON LANE UXBRIDGE Middlesex, England, GB Ub8 3pq |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-08 |
Decision Date | 1995-07-27 |