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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 K862602
Device Name AXION IV GOLDLINE SERIES
Applicant
Ventura Medical Electronics
6225 Lucile
Shawnee,  KS  66203
Applicant Contact JOSEPH F VENTURA
Correspondent
Ventura Medical Electronics
6225 Lucile
Shawnee,  KS  66203
Correspondent Contact JOSEPH F VENTURA
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/08/1986
Decision Date 12/22/1986
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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