FDA 510(k) Application Details - K083352

Device Classification Name Electrosurgical Coagulation For Aesthetic

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510(K) Number K083352
Device Name Electrosurgical Coagulation For Aesthetic
Applicant NEWLANDS CLINICAL TRIALS LTD
220 RIVER ROAD
CLAREMONT, NH 03743 US
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Contact WILLIAM GREENROSE
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Regulation Number 878.4400

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Classification Product Code ONQ
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Date Received 11/13/2008
Decision Date 06/12/2009
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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