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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 K813501
Device Name TRANSCUTANEOUS ELEC. NERVE STIMULATOR
Applicant
EMPI
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EMPI
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/14/1981
Decision Date 12/29/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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