FDA 510(k) Application Details - K041554

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K041554
Device Name Powered Laser Surgical Instrument
Applicant AESTHERA CORPORATION
P.O. BOX 2608
MORGAN HILL, CA 95038 US
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Contact C. ROBERT PAYNE
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 06/10/2004
Decision Date 04/27/2005
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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