FDA 510(k) Application Details - K151023

Device Classification Name Scaler, Ultrasonic

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510(K) Number K151023
Device Name Scaler, Ultrasonic
Applicant MECTRON SPA
VIA LORETO 15
CARASCO 16042 IT
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Contact FRANCO ZUNINO
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 04/16/2015
Decision Date 08/05/2015
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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