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FDA 510(k) Application Details - K123494
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K123494
Device Name
Powered Laser Surgical Instrument
Applicant
CONVERGENT DENTAL, INC
611 WEST 5TH STREET
THIRD FLOOR
AUSTIN, TX 78701 US
Other 510(k) Applications for this Company
Contact
Carrie Hetrick
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/13/2012
Decision Date
02/11/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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