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FDA 510(k) Application Details - K003176
Device Classification Name
Device, Muscle Monitoring
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.1375
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Classification Product Code
KZM
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More FDA Info for this Product Code
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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