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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K223222
Device Name Plasma IQ
Applicant
Neauvia North America, Inc
8480 Honeycutt Road
Raleigh,  NC  27615
Applicant Contact Joy Willard
Correspondent
Neauvia North America, Inc
8480 Honeycutt Road
Raleigh,  NC  27615
Correspondent Contact Joy Willard
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/17/2022
Decision Date 01/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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