D.O.R.C. MICRODIATHERMY SYSTEM

Unit, Cautery, Thermal, Ac-powered

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. Microdiathermy System.

Pre-market Notification Details

Device IDK962135
510k NumberK962135
Device Name:D.O.R.C. MICRODIATHERMY SYSTEM
ClassificationUnit, Cautery, Thermal, Ac-powered
Applicant DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. P.O. BOX 968 Kingston,  NH  03848
ContactMark W Furlong
CorrespondentMark W Furlong
DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. P.O. BOX 968 Kingston,  NH  03848
Product CodeHQO  
CFR Regulation Number886.4115 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-03
Decision Date1996-08-29

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