D.O.R.C. HEXON ILLUMINATION SYSTEM

Endoilluminator

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. Hexon Illumination System.

Pre-market Notification Details

Device IDK973229
510k NumberK973229
Device Name:D.O.R.C. HEXON ILLUMINATION SYSTEM
ClassificationEndoilluminator
Applicant DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. Kingston,  NH  03848
ContactMark W Furlong
CorrespondentMark W Furlong
DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. Kingston,  NH  03848
Product CodeMPA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-27
Decision Date1997-11-25
Summary:summary

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