Cleared Traditional

K820511 - BAUSCH & LOMB STERILE ALL PURPOSE SOLU (FDA 510(k) Clearance)

Apr 1982
Decision
45d
Days
-
Risk

K820511 is an FDA 510(k) clearance for the BAUSCH & LOMB STERILE ALL PURPOSE SOLU. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 9, 1982, 45 days after receiving the submission on February 23, 1982.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K820511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1982
Decision Date April 09, 1982
Days to Decision 45 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

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