FDA 510(k) Application Details - K003176

Device Classification Name Device, Muscle Monitoring

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510(K) Number K003176
Device Name Device, Muscle Monitoring
Applicant BIO-RESEARCH ASSOCIATES, INC.
4113 NORTH PORT WASHINGTON RD.
MILWAUKEE, WI 53212 US
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Contact JOHN C RADKE
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Regulation Number 890.1375

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Classification Product Code KZM
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Date Received 10/11/2000
Decision Date 01/04/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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