Cleared Traditional

K980147 - YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
(FDA 510(k) Clearance)

K980147 · Automatic Liquid Packaging, Inc. · Ophthalmic
Apr 1998
Decision
88d
Days
Class 2
Risk

K980147 is an FDA 510(k) clearance for the YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Automatic Liquid Packaging, Inc. (Chicago, US). The FDA issued a Cleared decision on April 13, 1998, 88 days after receiving the submission on January 15, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K980147 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 1998
Decision Date April 13, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

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

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