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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K953814
Device Name OTOSCAPE
Applicant
Soundscape Technologies, Inc.
3330 Hospital Dr., NW
Rm. 193
Calgary,  CA
Applicant Contact BARRY KIMBERLEY
Correspondent
Soundscape Technologies, Inc.
3330 Hospital Dr., NW
Rm. 193
Calgary,  CA
Correspondent Contact BARRY KIMBERLEY
Regulation Number874.1050
Classification Product Code
EWO  
Date Received08/14/1995
Decision Date 12/21/1995
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
Predetermined Change
Control Plan Authorized		 No
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