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FDA 510(k) Application Details - K072344
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K072344
Device Name
Powered Laser Surgical Instrument
Applicant
BIOS S.R.L.
VIA GUIDO ROSSA, 10/12
VIMODRONE (MILAN) I-20090 IT
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Contact
ALDO CASALINO
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
08/21/2007
Decision Date
12/03/2007
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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