FDA 510(k) Application Details - K050397

Device Classification Name Massager, Vacuum, Light Induced Heating

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510(K) Number K050397
Device Name Massager, Vacuum, Light Induced Heating
Applicant SYNERON MEDICAL LTD.
601 PENNSYLVANIA AVE., N.W.
WASHINGTON, DC 20004 US
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Contact DONALD E SEGAL
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Regulation Number 878.4810

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Classification Product Code NUV
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Date Received 02/16/2005
Decision Date 06/09/2005
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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