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FDA 510(k) Application Details - K992439
Device Classification Name
Device, Biofeedback
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510(K) Number
K992439
Device Name
Device, Biofeedback
Applicant
MYOTRONICS-NOROMED, INC.
15425 53RD AVE. SOUTH
TUKWILA, WA 98188 US
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FRAY ADIB
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Regulation Number
882.5050
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Classification Product Code
HCC
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Date Received
07/22/1999
Decision Date
08/13/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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