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FDA 510(k) Application Details - K093723
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K093723
Device Name
Scaler, Ultrasonic
Applicant
EMS ELECTRO MEDICAL SYSTEMS SA
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact
CYNTHIA J.M. NOLTE
Other 510(k) Applications for this Contact
Regulation Number
872.4850
More FDA Info for this Regulation Number
Classification Product Code
ELC
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More FDA Info for this Product Code
Date Received
12/03/2009
Decision Date
09/08/2010
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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