FDA 510(k) Application Details - K043373

Device Classification Name Device, Muscle Monitoring

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510(K) Number K043373
Device Name Device, Muscle Monitoring
Applicant NEUROMUSCULAR TECHNOLOGIES, INC.
17720 JEAN WAY
#200
LAKE OSWEGO, OR 97035 US
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Contact MARIE JENSEN
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Regulation Number 890.1375

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Classification Product Code KZM
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Date Received 12/08/2004
Decision Date 09/02/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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