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FDA 510(k) Application Details - K110243
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K110243
Device Name
Powered Laser Surgical Instrument
Applicant
MEDART A/S
CLOS LLYN CWM
SWANSEA, WALES SA6 8QY GB
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Contact
JOANNE DAVIES
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
01/27/2011
Decision Date
06/28/2011
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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