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FDA 510(k) Application Details - K032191
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K032191
Device Name
Powered Laser Surgical Instrument
Applicant
LUXSANO AB
908 STETSON STREET
WOODLAND, CA 95776 US
Other 510(k) Applications for this Company
Contact
Connie Hoy
Other 510(k) Applications for this Contact
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
07/17/2003
Decision Date
08/20/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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