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FDA 510(k) Application Details - K062549
Device Classification Name
Stimulator, Nerve
More FDA Info for this Device
510(K) Number
K062549
Device Name
Stimulator, Nerve
Applicant
EXCEL TECH. LTD.
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO L6H 5S1 CA
Other 510(k) Applications for this Company
Contact
NICOLE LANDREVILLE
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
08/30/2006
Decision Date
10/04/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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