Cleared Traditional

BOSTON CLEANER II

K923437 · Polymer Technology Corp. · Ophthalmic
Oct 1992
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K923437 is an FDA 510(k) clearance for the BOSTON CLEANER II, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Polymer Technology Corp. (Rochester, US). The FDA issued a Cleared decision on October 28, 1992, 107 days after receiving the submission on July 13, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K923437 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1992
Decision Date October 28, 1992
Days to Decision 107 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

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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