Cleared Traditional

INFUSION SLEEVE - OPHTHALMIC

K851009 · Medical Instrument Development Laboratories, Inc. · Ophthalmic
Apr 1985
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K851009 is an FDA 510(k) clearance for the INFUSION SLEEVE - OPHTHALMIC, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Medical Instrument Development Laboratories, Inc. (San Leandro, US). The FDA issued a Cleared decision on April 3, 1985, 22 days after receiving the submission on March 12, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K851009 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 1985
Decision Date April 03, 1985
Days to Decision 22 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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