FDA 510(k) Application Details - K961079

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K961079
Device Name Powered Laser Surgical Instrument
Applicant LASER PERIPHERALS LLC.
5484 FELTL RD.
MINNETONKA, MN 55343 US
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Contact NANCY L ARNOLD
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 03/18/1996
Decision Date 05/22/1996
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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