FDA 510(k) Application Details - K062048

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K062048
Device Name Powered Laser Surgical Instrument
Applicant AESTHERA CORPORATION
3637 BERNAL AVENUE
PLEASANTON, CA 94566 US
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Contact ANNE WORDEN
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 07/20/2006
Decision Date 09/07/2006
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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