FDA 510(k) Application Details - K033764

Device Classification Name Scaler, Ultrasonic

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510(K) Number K033764
Device Name Scaler, Ultrasonic
Applicant SATELEC
Z.I. DU PHARE, B.P. 216
17, AVENUE GUSTAVE EIFFEL
MERIGNAC CEDEX 33708 FR
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Contact PASCAL DUPEYRON
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 12/02/2003
Decision Date 03/01/2004
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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