FDA 510(k) Application Details - K053578

Device Classification Name Scaler, Ultrasonic

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510(K) Number K053578
Device Name Scaler, Ultrasonic
Applicant SCORPION
333 MILFORD ROAD
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 12/22/2005
Decision Date 07/14/2006
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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