Cleared Traditional

K820818 - CONCENTRATED CLEANER FOR HARD CONTACTS (FDA 510(k) Clearance)

Apr 1982
Decision
16d
Days
-
Risk

K820818 is an FDA 510(k) clearance for the CONCENTRATED CLEANER FOR HARD CONTACTS. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 9, 1982, 16 days after receiving the submission on March 24, 1982.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K820818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1982
Decision Date April 09, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

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