MARE DENTAL OPERATIVE UNIT

Unit, Operative Dental

DENIMED ELECTRONICA S.H.

The following data is part of a premarket notification filed by Denimed Electronica S.h. with the FDA for Mare Dental Operative Unit.

Pre-market Notification Details

Device IDK041458
510k NumberK041458
Device Name:MARE DENTAL OPERATIVE UNIT
ClassificationUnit, Operative Dental
Applicant DENIMED ELECTRONICA S.H. 1460 NW 107 AVE. SUITE G Miami,  FL  33172
ContactGeorge Echeverri
CorrespondentGeorge Echeverri
DENIMED ELECTRONICA S.H. 1460 NW 107 AVE. SUITE G Miami,  FL  33172
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-01
Decision Date2004-08-24
Summary:summary

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