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FDA 510(k) Application Details - K083352
Device Classification Name
Electrosurgical Coagulation For Aesthetic
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
ONQ
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More FDA Info for this Product Code
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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