FDA 510(k) Application Details - K090025

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K090025
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant SYNERON MEDICAL LTD.
P.O. BOX 550
INDUSTRIAL ZONE
YOKNEAM ILLIT 20692 IL
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Contact YONI IGER
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 01/05/2009
Decision Date 01/08/2010
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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