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FDA 510(k) Application Details - K092800
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K092800
Device Name
Powered Light Based Non-Laser Surgical Instrument
Applicant
LED INTELLECTUAL PROPERTIES, LLC
1131 ANTHEM VIEW LANE
KNOXVILLE, TN 37922 US
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Contact
ROBERT T WAGNER
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
ONE
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More FDA Info for this Product Code
Date Received
09/11/2009
Decision Date
02/04/2010
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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