Cleared Traditional

D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM

K010082 · Dutch Ophthalmic USA, Inc. · Ophthalmic
Mar 2001
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K010082 is an FDA 510(k) clearance for the D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Dutch Ophthalmic USA, Inc. (Kingston, US). The FDA issued a Cleared decision on March 12, 2001, 61 days after receiving the submission on January 10, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K010082 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2001
Decision Date March 12, 2001
Days to Decision 61 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150

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