FDA 510(k) Application Details - K102639

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K102639
Device Name Powered Laser Surgical Instrument
Applicant DISCUS DENTAL, LLC
8550 HIGUERA ST.
CULVER CITY, CA 90232 US
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Contact CLARK D VONAHSEN
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 09/14/2010
Decision Date 12/01/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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