FDA 510(k) Application Details - K170758

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K170758
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Solta Medical
11720 North Creek Pkwy N., Suite 100
Bothell, WA 98011 US
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Contact Melissa Thomas
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 03/13/2017
Decision Date 09/22/2017
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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