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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K212355
Device Name Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
Applicant
Checkpoint Surgical
6050 Oak Tree Blvd., Suite 360
Cleveland,  OH  44131
Applicant Contact Ben Cottrill
Correspondent
Checkpoint Surgical
6050 Oak Tree Blvd., Suite 360
Cleveland,  OH  44131
Correspondent Contact Ben Cottrill
Regulation Number874.1820
Classification Product Code
ETN  
Date Received07/29/2021
Decision Date 08/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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