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FDA 510(k) Application Details - K052310
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K052310
Device Name
Powered Laser Surgical Instrument
Applicant
UNIPHY ELEKTROMEDIZIN GMBH & CO. KG
6A PASWEG
BILZEN 3740 BE
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Contact
NICO BEUN
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
08/24/2005
Decision Date
03/15/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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