ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1

Scaler, Ultrasonic

BONART CO. LTD.

The following data is part of a premarket notification filed by Bonart Co. Ltd. with the FDA for Art-m3 25k, Model M3-1-art2-a1; Art-m3 30k, Model M3-1-art3-a1.

Pre-market Notification Details

Device IDK994203
510k NumberK994203
Device Name:ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1
ClassificationScaler, Ultrasonic
Applicant BONART CO. LTD. RM. 405, NO.3 WUCHUAN 1ST ROAD Hsinchuang, Taipei,  TW
ContactBankson Tsai
CorrespondentBankson Tsai
BONART CO. LTD. RM. 405, NO.3 WUCHUAN 1ST ROAD Hsinchuang, Taipei,  TW
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-13
Decision Date2000-03-06
Summary:summary

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