Cleared Traditional

K821054 - TOTAL (FDA 510(k) Clearance)

K821054 · Allergan, Inc. · Ophthalmic device
May 1982
Decision
28d
Days
-
Risk

K821054 is an FDA 510(k) clearance for the TOTAL. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Allergan, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1982, 28 days after receiving the submission on April 15, 1982.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K821054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1982
Decision Date May 13, 1982
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

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