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FDA 510(k) Application Details - K092292
Device Classification Name
Stimulator, Nerve
More FDA Info for this Device
510(K) Number
K092292
Device Name
Stimulator, Nerve
Applicant
NDI MEDICAL LLC
22901 MILLCREEK BOULEVARD
SUITE 110
CLEVELAND, OH 44122 US
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Contact
JULIE GRILL
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
07/29/2009
Decision Date
10/28/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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