Cleared Traditional

MICRO VIT FRAGMENTATION SYSTEM

K834537 · Medical Instrument Development Laboratories, Inc. · Ophthalmic
Mar 1984
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K834537 is an FDA 510(k) clearance for the MICRO VIT FRAGMENTATION SYSTEM, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Medical Instrument Development Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on March 16, 1984, 98 days after receiving the submission on December 9, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K834537 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 1983
Decision Date March 16, 1984
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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