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FDA 510(k) Application Details - K152769
Device Classification Name
Stimulator, Nerve
More FDA Info for this Device
510(K) Number
K152769
Device Name
Stimulator, Nerve
Applicant
AD-TECH MEDICAL INSTRUMENT CORPORATION
1901 WILLIAM STREET
RACINE, WI 53404 US
Other 510(k) Applications for this Company
Contact
LISA THEAMA
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
09/25/2015
Decision Date
05/06/2016
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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