COMPOTHIXO

Instruments, Dental Hand

KERRHAWE SA

The following data is part of a premarket notification filed by Kerrhawe Sa with the FDA for Compothixo.

Pre-market Notification Details

Device IDK111465
510k NumberK111465
Device Name:COMPOTHIXO
ClassificationInstruments, Dental Hand
Applicant KERRHAWE SA 1717 WEST COLLINS AVENUE Orange,  CA  92867
ContactWendy Garman
CorrespondentWendy Garman
KERRHAWE SA 1717 WEST COLLINS AVENUE Orange,  CA  92867
Product CodeDZN  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-26
Decision Date2012-07-25
Summary:summary

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