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FDA 510(k) Application Details - K983965
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K983965
Device Name
Powered Laser Surgical Instrument
Applicant
LASER, INC.
1803 BAKER DR.
TOMBALL, TX 77375-0434 US
Other 510(k) Applications for this Company
Contact
WILLIAM K PRZBYBLA
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
11/06/1998
Decision Date
12/22/1998
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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