FDA 510(k) Application Details - K071981

Device Classification Name Scaler, Ultrasonic

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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
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Regulation Number 872.4850

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Classification Product Code ELC
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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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