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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, Transcutaneous, Over-The-Counter
510(k) Number K182267
Device Name PAT (Pain Alleviation Technologies)
Applicant
Marchan Medical, LLC
165 S Ashe St.
Southern Pines,  NC  28387
Applicant Contact Mark Chandler
Correspondent
Marchan Medical, LLC
165 S Ashe St.
Southern Pines,  NC  28387
Correspondent Contact Mark Chandler
Regulation Number882.5890
Classification Product Code
NUH  
Date Received08/21/2018
Decision Date 02/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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