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FDA 510(k) Application Details - K042630
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K042630
Device Name
Powered Laser Surgical Instrument
Applicant
SKINCARE TECHNOLOGY INC.
70 W MADISON ST., SUITE 3300
CHICAGO, IL 60602 US
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Contact
RICHARD O WOOD
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
09/27/2004
Decision Date
06/27/2005
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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