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FDA 510(k) Application Details - K130137
Device Classification Name
Scaler, Ultrasonic
More FDA Info for this Device
510(K) Number
K130137
Device Name
Scaler, Ultrasonic
Applicant
COLTENE/WHALEDENT
5905 LAWN LANE
CLEVELAND, OH 44141 US
Other 510(k) Applications for this Company
Contact
EDWARD A KROLL
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
01/18/2013
Decision Date
08/23/2013
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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