Cleared Traditional

K865111 - CHARTER HARD CONTACT LENS CLEANING SOLUTION
(FDA 510(k) Clearance)

Jan 1987
Decision
20d
Days
Risk

K865111 is an FDA 510(k) clearance for the CHARTER HARD CONTACT LENS CLEANING SOLUTION. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Paco Pharmaceutical Services, Inc. (Lakewood, US). The FDA issued a Cleared decision on January 20, 1987, 20 days after receiving the submission on December 31, 1986.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K865111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1986
Decision Date January 20, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

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

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