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FDA 510(k) Application Details - K160905
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K160905
Device Name
Scaler, Ultrasonic
Applicant
SONENDO, INC.
26061 MERIT CIRCLE, SUITE 102
LAGUNA HILLS, CA 92653 US
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Contact
DAN W. MILLER
Other 510(k) Applications for this Contact
Regulation Number
872.4850
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Classification Product Code
ELC
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More FDA Info for this Product Code
Date Received
04/01/2016
Decision Date
06/03/2016
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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