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FDA 510(k) Application Details - K110989
Device Classification Name
Stimulator, Nerve
More FDA Info for this Device
510(K) Number
K110989
Device Name
Stimulator, Nerve
Applicant
NEUROVISION MEDICAL PRODUCTS, INC.
2225 SPERRY AVE, SUITE 1000
VENTURA, CA 93003 US
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Contact
CHRISTINE VERGELY
Other 510(k) Applications for this Contact
Regulation Number
874.1820
More FDA Info for this Regulation Number
Classification Product Code
ETN
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More FDA Info for this Product Code
Date Received
04/08/2011
Decision Date
11/03/2011
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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