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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 K884972
Device Name TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR
Applicant
FUTUREMED DIV. OF FUTURE IMPEX CORP.
2076 DEER PARK AVE.
DEER PARK,  NY  11729
Applicant Contact MORAD DAVOUDZADEH
Correspondent
FUTUREMED DIV. OF FUTURE IMPEX CORP.
2076 DEER PARK AVE.
DEER PARK,  NY  11729
Correspondent Contact MORAD DAVOUDZADEH
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/30/1988
Decision Date 07/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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