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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 K231872
Device Name Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)
Applicant
Kirwan Surgical Products, LLC
180 Enterprise Dr.
Marshfield,  MA  02050
Applicant Contact Matthew Prario
Correspondent
Kirwan Surgical Products, LLC
180 Enterprise Dr.
Marshfield,  MA  02050
Correspondent Contact Matthew Prario
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/26/2023
Decision Date 08/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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