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FDA 510(k) Application Details - K170500
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K170500
Device Name
Powered Laser Surgical Instrument
Applicant
Dentsply Sirona
221 West Philadelphia Street Suite 60W
York, PA 17401 US
Other 510(k) Applications for this Company
Contact
Karl J. Nittinger
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
02/21/2017
Decision Date
05/16/2017
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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