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FDA 510(k) Application Details - K132607
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K132607
Device Name
Powered Laser Surgical Instrument
Applicant
NEW STAR LASERS, INC.
2800 PLEASANT HILL RD. STE #175
PLEASANT HILL, CA 94523 US
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Contact
PAMELA M BUCKMAN, MSN
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
08/20/2013
Decision Date
03/21/2014
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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