Cleared Traditional

EPA AUTOMATED INFUSION POLE

K832997 · Miami Eye Technology, Inc. · Ophthalmic
Oct 1983
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K832997 is an FDA 510(k) clearance for the EPA AUTOMATED INFUSION POLE, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Miami Eye Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983, 32 days after receiving the submission on September 2, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K832997 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 1983
Decision Date October 04, 1983
Days to Decision 32 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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