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FDA 510(k) Application Details - K061850
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K061850
Device Name
Powered Laser Surgical Instrument
Applicant
AMERICAN LASERS, INC.
300 EAST MAIN ST.
ALHAMBRA, CA 91801 US
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Contact
DAVID K QUON
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
06/30/2006
Decision Date
09/29/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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