FDA 510(k) Application Details - K072906

Device Classification Name Powered Laser Surgical Instrument

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510(K) Number K072906
Device Name Powered Laser Surgical Instrument
Applicant HOME SKINOVATIONS LTD.
4 HACHAROSHET ST.
POB 7028
KFAR SABA 44640 IL
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Contact AMIR WALDMAN
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Regulation Number 878.4810

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Classification Product Code GEX
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Date Received 10/11/2007
Decision Date 01/23/2008
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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