MICRO 2 SYSTEM

Attachment, Precision, All

INODENT

The following data is part of a premarket notification filed by Inodent with the FDA for Micro 2 System.

Pre-market Notification Details

Device IDK900785
510k NumberK900785
Device Name:MICRO 2 SYSTEM
ClassificationAttachment, Precision, All
Applicant INODENT SUITE 120 CANAL SQUARE 1054 31ST STREET NW WASHINGTON,  DC  20007
ContactJEAN-PIERRE LACLAU
CorrespondentJEAN-PIERRE LACLAU
INODENT SUITE 120 CANAL SQUARE 1054 31ST STREET NW WASHINGTON,  DC  20007
Product CodeEGG  
CFR Regulation Number872.3165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-20
Decision Date1990-04-16

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