FDA 510(k) Application Details - K033705

Device Classification Name Scaler, Ultrasonic

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510(K) Number K033705
Device Name Scaler, Ultrasonic
Applicant DENTSPLY INTERNATIONAL
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK, PA 17404 US
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Contact P. JEFFERY LEHN
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 11/25/2003
Decision Date 12/04/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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