Cleared Traditional

K830740 - CLERZ LUBRICATING & REWETTING EYE DROPS (FDA 510(k) Clearance)

Jun 1983
Decision
86d
Days
Risk

K830740 is an FDA 510(k) clearance for the CLERZ LUBRICATING & REWETTING EYE DROPS. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on June 2, 1983, 86 days after receiving the submission on March 8, 1983.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K830740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1983
Decision Date June 02, 1983
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HPX — Lens, Contact (polymethylmethacrylate)
Device Class