Cleared Traditional

K822707 - CLEAN-N-SOAK (FDA 510(k) Clearance)

Oct 1982
Decision
41d
Days
-
Risk

K822707 is an FDA 510(k) clearance for the CLEAN-N-SOAK. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Allergan, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1982, 41 days after receiving the submission on September 7, 1982.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K822707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1982
Decision Date October 18, 1982
Days to Decision 41 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

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