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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 K071869
Device Name TENS/IF 14
Applicant
EMSI
901 KING STREET
SUITE 200
ALEXANDRIA,  VA  22331
Applicant Contact CHERITA JAMES
Correspondent
EMSI
901 KING STREET
SUITE 200
ALEXANDRIA,  VA  22331
Correspondent Contact CHERITA JAMES
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
LIH  
Date Received07/06/2007
Decision Date 03/07/2008
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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