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FDA 510(k) Application Details - K041569
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K041569
Device Name
Powered Laser Surgical Instrument
Applicant
CURELIGHT LTD
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact
JONATHAN S KAHN
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
06/10/2004
Decision Date
06/30/2004
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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