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FDA 510(k) Application Details - K060326
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K060326
Device Name
Powered Laser Surgical Instrument
Applicant
PROSURG, INC.
2193 TRADE ZONE BLVD.
SAN JOSE, CA 95131 US
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ASHVIN DESAI
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
02/09/2006
Decision Date
04/05/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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