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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drill, bone, powered
510(k) Number K112188
Device Name PIEZOTOME SOLO
Original Applicant
SATELEC - ACTEON, INC.
124 gaither dr., suite 140
mount laurel,  NJ  08054
Original Contact rick rosati
Regulation Number872.4120
Classification Product Code
DZI  
Date Received07/29/2011
Decision Date 02/03/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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