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FDA 510(k) Application Details - K111350
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
More FDA Info for this Device
510(K) Number
K111350
Device Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant
MEDICAM INC.
7900 JEAN-BRILLON
MONTREAL, QUEBEC H8N 2L5 CA
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Contact
PHILIPPE AMAR
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Regulation Number
878.4810
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Classification Product Code
ONF
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More FDA Info for this Product Code
Date Received
05/13/2011
Decision Date
09/29/2011
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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