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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K854720
Device Name NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM.
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 Number890.5850
Classification Product Code
IPF  
Date Received11/22/1985
Decision Date 03/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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