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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, For Pain Relief
510(k) Number K083250
Device Name NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
Applicant
AA NEUROMED CORP.
1911 RODGER AVENUE
PORT COQUITLAM, BC,  CA V3C 1B8
Applicant Contact HERMANN DOLKER
Correspondent
AA NEUROMED CORP.
1911 RODGER AVENUE
PORT COQUITLAM, BC,  CA V3C 1B8
Correspondent Contact HERMANN DOLKER
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   LIH  
Date Received11/04/2008
Decision Date 08/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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