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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 K972373
Device Name OVATION HDP
Applicant
Orsonique, Inc.
4025 Blvd. Industriel, #100
Laval, Quebec,  CA H7L 4S3
Applicant Contact EUGENE ALEXANDRESCU
Correspondent
Orsonique, Inc.
4025 Blvd. Industriel, #100
Laval, Quebec,  CA H7L 4S3
Correspondent Contact EUGENE ALEXANDRESCU
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/25/1997
Decision Date 07/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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