Cleared Traditional

K852384 - SIGHT SAVER ALL PURPOSE LENS CARRYING CASE (FDA 510(k) Clearance)

Jul 1985
Decision
56d
Days
-
Risk

K852384 is an FDA 510(k) clearance for the SIGHT SAVER ALL PURPOSE 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 July 31, 1985, 56 days after receiving the submission on June 5, 1985.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K852384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1985
Decision Date July 31, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

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