Cleared Traditional

BOSTON CONTACT LENS CASE

K951552 · Polymer Technology Corp. · Ophthalmic
Jun 1995
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K951552 is an FDA 510(k) clearance for the BOSTON CONTACT LENS CASE, a Case, Contact Lens (Class II — Special Controls, product code LRX), submitted by Polymer Technology Corp. (Rochester, US). The FDA issued a Cleared decision on June 26, 1995, 83 days after receiving the submission on April 4, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K951552 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1995
Decision Date June 26, 1995
Days to Decision 83 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LRX — Case, Contact Lens
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5928

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