Cleared Traditional

BOSTON ADVANCE CLEANER

K974466 · Polymer Technology Corp. · Ophthalmic
Feb 1998
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K974466 is an FDA 510(k) clearance for the BOSTON ADVANCE CLEANER, a Products, Contact Lens Care, Rigid Gas Permeable (Class II — Special Controls, product code MRC), submitted by Polymer Technology Corp. (Rochester, US). The FDA issued a Cleared decision on February 19, 1998, 85 days after receiving the submission on November 26, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.

Submission Details

510(k) Number K974466 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1997
Decision Date February 19, 1998
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MRC — Products, Contact Lens Care, Rigid Gas Permeable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5918

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