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FDA 510(k) Application Details - K022328
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K022328
Device Name
Scaler, Ultrasonic
Applicant
ELECTRO MEDICAL SYSTEMS SA
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
Other 510(k) Applications for this Company
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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/18/2002
Decision Date
08/13/2002
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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