MICRODOSE RC-EZ

Gutta-percha

UNICEP

The following data is part of a premarket notification filed by Unicep with the FDA for Microdose Rc-ez.

Pre-market Notification Details

Device IDK924825
510k NumberK924825
Device Name:MICRODOSE RC-EZ
ClassificationGutta-percha
Applicant UNICEP P.O. BOX 1827 804 AIRPORT WAY Sandpoint,  ID  83864
ContactJohn Snedden
CorrespondentJohn Snedden
UNICEP P.O. BOX 1827 804 AIRPORT WAY Sandpoint,  ID  83864
Product CodeEKM  
CFR Regulation Number872.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-28
Decision Date1993-03-05

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