DORC VITRECTOMY LENSES, MODEL 1284 SERIES— 510(k) K033950

Name: FDA 510(k) clearance K033950
Creator: U.S. Food and Drug Administration
Published: 2004-02-20

Substantially Equivalent

Dutch Ophthalmic Research Center (D.O.R.C.)

FDA 510(k) clearance K033950 for DORC VITRECTOMY LENSES, MODEL 1284 SERIES, Substantially Equivalent on 2004-02-20. Applicant: Dutch Ophthalmic Research Center (D.O.R.C.). Device class: 2.

Clearance details

Applicant: Dutch Ophthalmic Research Center (D.O.R.C.)
Product code: Code HJK
Device class: Class 2
Regulation: 21 CFR 886.1385
Advisory panel: Ophthalmic
Date received: 2003-12-22
Decision date: 2004-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, NH, US

Download summary PDF View on FDA.gov ↗

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