D.O.R.C. VFI/VFE SYSTEM

Device, Irrigation, Ocular Surgery

DUTCH OPHTHALMIC USA, INC.

The following data is part of a premarket notification filed by Dutch Ophthalmic Usa, Inc. with the FDA for D.o.r.c. Vfi/vfe System.

Pre-market Notification Details

Device IDK954842
510k NumberK954842
Device Name:D.O.R.C. VFI/VFE SYSTEM
ClassificationDevice, Irrigation, Ocular Surgery
Applicant DUTCH OPHTHALMIC USA, INC. TWO MARSHALL RD. Kingston,  NH  03848
ContactMark W Furlong
CorrespondentMark W Furlong
DUTCH OPHTHALMIC USA, INC. TWO MARSHALL RD. Kingston,  NH  03848
Product CodeKYG  
CFR Regulation Number886.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-23
Decision Date1996-04-15

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