Cleared Traditional

BOSTON(R) 7 - 30(ENFLUFOCON A)

K943177 · Polymer Technology Corp. · Ophthalmic
Aug 1994
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K943177 is an FDA 510(k) clearance for the BOSTON(R) 7 - 30(ENFLUFOCON A), a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Polymer Technology Corp. (Rochester, US). The FDA issued a Cleared decision on August 25, 1994, 55 days after receiving the submission on July 1, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K943177 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1994
Decision Date August 25, 1994
Days to Decision 55 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HQD — Lens, Contact (other Material) - Daily
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5916

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