Cleared Traditional

K843511 - BAUSCH & LOMB CLEANING PAD (FDA 510(k) Clearance)

Oct 1986
Decision
770d
Days
Class 2
Risk

K843511 is an FDA 510(k) clearance for the BAUSCH & LOMB CLEANING PAD. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on October 16, 1986, 770 days after receiving the submission on September 6, 1984.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K843511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date October 16, 1986
Days to Decision 770 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

Product Code LPN - Accessories, Soft Lens Products
Device Class Class II - Special Controls
CFR Regulation 21 CFR 886.5928