Cleared Traditional

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

K983797 · Dutch Ophthalmic USA, Inc. · Ophthalmic
Mar 1999
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K983797 is an FDA 510(k) clearance for the D.O.R.C. HARMONY TOTAL 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 3, 1999, 126 days after receiving the submission on October 28, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K983797 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1998
Decision Date March 03, 1999
Days to Decision 126 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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