D.O.R.C. Disposable Cryo Probe— 510(k) K160591

Name: FDA 510(k) clearance K160591
Creator: U.S. Food and Drug Administration
Published: 2017-01-23

Substantially Equivalent

Dutch Ophthalmic Research Center International BV

FDA 510(k) clearance K160591 for D.O.R.C. Disposable Cryo Probe, Substantially Equivalent on 2017-01-23. Applicant: Dutch Ophthalmic Research Center International BV. Device class: 2.

Clearance details

Applicant: Dutch Ophthalmic Research Center International BV
Product code: Code HRN
Device class: Class 2
Regulation: 21 CFR 886.4170
Advisory panel: Ophthalmic
Date received: 2016-03-01
Decision date: 2017-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zuidland, NL

Download summary PDF View on FDA.gov ↗

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