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FDA 510(k) Application Details - K092729
Device Classification Name
Stimulator, Nerve
More FDA Info for this Device
510(K) Number
K092729
Device Name
Stimulator, Nerve
Applicant
BAXANO, INC.
1171 BARROILHET AVENUE
HILLSBOROUGH, CA 94010-6577 US
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Contact
CINDY DOMECUS
Other 510(k) Applications for this Contact
Regulation Number
874.1820
More FDA Info for this Regulation Number
Classification Product Code
ETN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/04/2009
Decision Date
10/02/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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