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FDA 510(k) Application Details - K963821
Device Classification Name
Hearing Aid, Air Conduction
More FDA Info for this Device
510(K) Number
K963821
Device Name
Hearing Aid, Air Conduction
Applicant
ORSONIQUE, INC.
4025 BOUL. INDUSTRIEL
SUITE #100
LAVAL, QUEBEC H7L 4S3 CA
Other 510(k) Applications for this Company
Contact
EUGENE ALEXANDRESCU
Other 510(k) Applications for this Contact
Regulation Number
874.3300
More FDA Info for this Regulation Number
Classification Product Code
ESD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/23/1996
Decision Date
10/28/1996
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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