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FDA 510(k) Application Details - K033259
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K033259
Device Name
Powered Laser Surgical Instrument
Applicant
LIGHT AGE, INC.
500 APGAR DRIVE
SOMERSET, NJ 08873-1150 US
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THOMAS HAUCK
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
10/09/2003
Decision Date
02/25/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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