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FDA 510(k) Application Details - K171055
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K171055
Device Name
Powered Light Based Non-Laser Surgical Instrument
Applicant
Philips Electronics Nederland B.V.
High Tech Campus 5
Eindhoven 5656 AE NL
Other 510(k) Applications for this Company
Contact
Gaozhen Hang
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
ONE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/10/2017
Decision Date
07/06/2017
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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