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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Muscle Monitoring
510(k) Number K003287
Device Name MODEL K7 EVALUATION DEVICE
Applicant
Myotronics-Noromed, Inc.
15425 53rd Ave. S.
Tukwila,  WA  98188
Applicant Contact FRAY ADIB
Correspondent
Myotronics-Noromed, Inc.
15425 53rd Ave. S.
Tukwila,  WA  98188
Correspondent Contact FRAY ADIB
Regulation Number890.1375
Classification Product Code
KZM  
Date Received10/20/2000
Decision Date 11/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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