Cleared Traditional

K821055 - BLINK-N-CLEAN (FDA 510(k) Clearance)

K821055 · Allergan, Inc. · Ophthalmic device
May 1982
Decision
25d
Days
-
Risk

K821055 is an FDA 510(k) clearance for the BLINK-N-CLEAN. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Allergan, Inc. (Walker, US). The FDA issued a Cleared decision on May 10, 1982, 25 days after receiving the submission on April 15, 1982.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K821055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1982
Decision Date May 10, 1982
Days to Decision 25 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

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