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FDA 510(k) Application Details - K990538
Device Classification Name
Device, Biofeedback
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510(K) Number
K990538
Device Name
Device, Biofeedback
Applicant
BRAINMASTER
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
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
02/19/1999
Decision Date
05/19/1999
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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