FDA 510(k) Application Details - K111026

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K111026
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant POLLOGEN LTD
31 HAAVODA ST.
BINYAMINA 30500 IL
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Contact YORAM LEVY
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 04/13/2011
Decision Date 11/16/2011
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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