MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI

Activator, Ultraviolet, For Polymerization

SATELEC

The following data is part of a premarket notification filed by Satelec with the FDA for Mini L.e.d., Model: Mini L.e.d., Model Smartlite Mini.

Pre-market Notification Details

Device IDK032465
510k NumberK032465
Device Name:MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI
ClassificationActivator, Ultraviolet, For Polymerization
Applicant SATELEC 70 WALNUT ST. Wellesley,  MA  02481
ContactJacqueline E Masse
CorrespondentJacqueline E Masse
SATELEC 70 WALNUT ST. Wellesley,  MA  02481
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-11
Decision Date2003-10-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00190746007910 K032465 000
00190746007903 K032465 000
00190746007897 K032465 000
03609820052519 K032465 000
03609820052502 K032465 000
03609820052229 K032465 000
03609820052212 K032465 000

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