FDA 510(k) Application Details - K070975

Device Classification Name Scaler, Ultrasonic

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510(K) Number K070975
Device Name Scaler, Ultrasonic
Applicant HU-FRIEDY MFG. CO., INC
3232 N. ROCKWELL STREET
CHICAGO, IL 60618 US
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Contact KEITH DUNN
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 04/06/2007
Decision Date 06/21/2007
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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