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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K963818
Device Name OVATION AGC-2
Applicant
ORSONIQUE, INC.
4025 BOUL. INDUSTRIEL
SUITE #100
LAVAL, QUEBEC,  CA H7L 4S3
Applicant Contact EUGENE ALEXANDRESCU
Correspondent
ORSONIQUE, INC.
4025 BOUL. INDUSTRIEL
SUITE #100
LAVAL, QUEBEC,  CA H7L 4S3
Correspondent Contact EUGENE ALEXANDRESCU
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/23/1996
Decision Date 10/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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