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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K854721
Device Name NEMECTRODYN MODEL 2 & ENDOVAC 2
Applicant
Nemectron Medical, Inc.
28069 Diaz Rd. Unit A
Temecula,  CA  92590
Applicant Contact JUERGEN F KOPF
Correspondent
Nemectron Medical, Inc.
28069 Diaz Rd. Unit A
Temecula,  CA  92590
Correspondent Contact JUERGEN F KOPF
Regulation Number882.5890
Classification Product Code
LIH  
Date Received11/22/1985
Decision Date 03/06/1986
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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