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FDA 510(k) Application Details - K000510
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K000510
Device Name
Scaler, Ultrasonic
Applicant
BONART CO. LTD.
RM. 405, NO.3 WUCHUAN 1ST ROAD
HSINCHUANG, TAIPEI TW
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Contact
BANKSON TSAI
Other 510(k) Applications for this Contact
Regulation Number
872.4850
More FDA Info for this Regulation Number
Classification Product Code
ELC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/15/2000
Decision Date
05/15/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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