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FDA 510(k) Application Details - K071981
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K071981
Device Name
Scaler, Ultrasonic
Applicant
BONART CO. LTD.
398 S. LEMON CREEK DR.
STE. L
WALNUT, CA 91789 US
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Contact
ERIC L ONG
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
07/18/2007
Decision Date
10/26/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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