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FDA 510(k) Application Details - K110173
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K110173
Device Name
Scaler, Ultrasonic
Applicant
EMS ELECTRO MEDICAL SYSTEMS SA
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
Other 510(k) Applications for this Company
Contact
CYNTHIA J M. NOLTE, PH.D, RAC
Other 510(k) Applications for this Contact
Regulation Number
872.4850
More FDA Info for this Regulation Number
Classification Product Code
ELC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/20/2011
Decision Date
04/07/2011
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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