Cleared Traditional

K854968 - BAUSCH & LOMB LENS CARRYING CASE (FDA 510(k) Clearance)

Apr 1986
Decision
114d
Days
-
Risk

K854968 is an FDA 510(k) clearance for the BAUSCH & LOMB LENS CARRYING CASE. This device is classified as a Lens, Contact (polymethylmethacrylate).

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on April 4, 1986, 114 days after receiving the submission on December 11, 1985.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K854968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1985
Decision Date April 04, 1986
Days to Decision 114 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

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