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FDA 510(k) Application Details - K201631
Device Classification Name
Cuff, Nerve
More FDA Info for this Device
510(K) Number
K201631
Device Name
Cuff, Nerve
Applicant
Alafair Biosciences Inc
6101 W Courtyard Drive ste 2-225
Austin, TX 78730 US
Other 510(k) Applications for this Company
Contact
Angela Mallery
Other 510(k) Applications for this Contact
Regulation Number
882.5275
More FDA Info for this Regulation Number
Classification Product Code
JXI
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More FDA Info for this Product Code
Date Received
06/16/2020
Decision Date
09/14/2020
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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