FDA 510(k) Application Details - K003287

Device Classification Name Device, Muscle Monitoring

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510(K) Number K003287
Device Name Device, Muscle Monitoring
Applicant MYOTRONICS-NOROMED, INC.
15425 53RD AVE. SOUTH
TUKWILA, WA 98188 US
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Contact FRAY ADIB
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Regulation Number 890.1375

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Classification Product Code KZM
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Date Received 10/20/2000
Decision Date 11/06/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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