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FDA 510(k) Application Details - K924313
Device Classification Name
Device, Biofeedback
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510(K) Number
K924313
Device Name
Device, Biofeedback
Applicant
THE JAYMS CO.
432 NORTH 750 EAST
LINDON, UT 84042 US
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Contact
MARK GALLOWAY
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Regulation Number
882.5050
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Classification Product Code
HCC
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More FDA Info for this Product Code
Date Received
08/26/1992
Decision Date
03/14/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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