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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 K844638
Device Name ELECTROCAINE MODEL SR-IV
Applicant
Electrocaine Medical System
1100 Gelendon Ave.
Suite 818
Los Angeles,  CA  90024
Applicant Contact EDWARD A NAUMAN
Correspondent
Electrocaine Medical System
1100 Gelendon Ave.
Suite 818
Los Angeles,  CA  90024
Correspondent Contact EDWARD A NAUMAN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/28/1984
Decision Date 01/08/1985
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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