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FDA 510(k) Application Details - K070185
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K070185
Device Name
Powered Laser Surgical Instrument
Applicant
PHAROS LIFE CORPORATION
11-380 JAMIESON PKWY
CAMBRIDGE, ONTARIO N3C 4N4 CA
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Contact
PHIL CUSCUNA
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Regulation Number
878.4810
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Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
01/19/2007
Decision Date
08/21/2007
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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