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FDA 510(k) Application Details - K020697
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K020697
Device Name
Powered Laser Surgical Instrument
Applicant
DEPILASE GROUP LTD.
ONE CANADA SQUARE
CANARY WHARF
LONDON E14 5DY GB
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Contact
MARIO RUSSO
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/04/2002
Decision Date
04/12/2002
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
Y
Expedited Review
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