Cleared Traditional

K822706 - PRE-SERT (FDA 510(k) Clearance)

K822706 · Allergan, Inc. · Ophthalmic device
Oct 1982
Decision
45d
Days
-
Risk

K822706 is an FDA 510(k) clearance for the PRE-SERT. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Allergan, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 22, 1982, 45 days after receiving the submission on September 7, 1982.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K822706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1982
Decision Date October 22, 1982
Days to Decision 45 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

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