Cleared Traditional

MANDELKORN SUTURE LYSIS LENS

K933976 · Ocular Instruments, Inc. · Ophthalmic
Nov 1994
Decision
452d
Days
Class 2
Risk

About This 510(k) Submission

K933976 is an FDA 510(k) clearance for the MANDELKORN SUTURE LYSIS LENS, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on November 8, 1994, 452 days after receiving the submission on August 13, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K933976 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 1993
Decision Date November 08, 1994
Days to Decision 452 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HJK — Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1385

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