Cleared Traditional

STERILIZED DISPOS. CYSTOTOME

K840442 · Microsurgical Technology, Inc. · Ophthalmic
Mar 1984
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K840442 is an FDA 510(k) clearance for the STERILIZED DISPOS. CYSTOTOME, a Cannula, Ophthalmic (Class I — General Controls, product code HMX), submitted by Microsurgical Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1984, 44 days after receiving the submission on February 1, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K840442 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1984
Decision Date March 16, 1984
Days to Decision 44 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HMX — Cannula, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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