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FDA 510(k) Application Details - K011964
Device Classification Name
Device, Biofeedback
More FDA Info for this Device
510(K) Number
K011964
Device Name
Device, Biofeedback
Applicant
FASSTECH
155 MIDDLESEX TURNPIKE
BURLINGTON, MA 01803 US
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Contact
LEE BRODY
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
06/25/2001
Decision Date
09/20/2001
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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