FDA 510(k) Application Details - K992855

Device Classification Name

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510(K) Number K992855
Device Name XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
Applicant XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216-0980 US
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Contact DAVID TIMLIN
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Regulation Number

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Classification Product Code QPB
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Date Received 08/24/1999
Decision Date 01/21/2000
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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