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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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More FDA Info for this Product Code
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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