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FDA 510(k) Application Details - K963202
Device Classification Name
Device, Biofeedback
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510(K) Number
K963202
Device Name
Device, Biofeedback
Applicant
MEGA ELECTRONICS LTD.
1660 RIVERTON POINT
EAGAN, MN 55122 US
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Contact
GREGORY J MATHISON
Other 510(k) Applications for this Contact
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
08/15/1996
Decision Date
05/19/1997
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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