Cleared Traditional

K003252 - COMPLETE BRAND MULTI-PURPOSE SOLUTION (FDA 510(k) Clearance)

Feb 2001
Decision
127d
Days
Class 2
Risk

K003252 is an FDA 510(k) clearance for the COMPLETE BRAND MULTI-PURPOSE SOLUTION. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on February 21, 2001, 127 days after receiving the submission on October 17, 2000.

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

Submission Details

510(k) Number K003252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2000
Decision Date February 21, 2001
Days to Decision 127 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