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FDA 510(k) Application Details - K061448
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K061448
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
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More FDA Info for this Product Code
Date Received
05/22/2006
Decision Date
08/17/2006
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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