D.O.R.C. Disposable Cryo Probe

Unit, Cryophthalmic, Ac-powered

DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV

The following data is part of a premarket notification filed by Dutch Ophthalmic Research Center International Bv with the FDA for D.o.r.c. Disposable Cryo Probe.

Pre-market Notification Details

Device IDK160591
510k NumberK160591
Device Name:D.O.R.C. Disposable Cryo Probe
ClassificationUnit, Cryophthalmic, Ac-powered
Applicant DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEWEG 2 Zuidland,  NL 3214 Vn
ContactDanielle Sleegers
CorrespondentDanielle Sleegers
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEWEG 2 Zuidland,  NL 3214 Vn
Product CodeHRN  
CFR Regulation Number886.4170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-01
Decision Date2017-01-23
Summary:summary

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