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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, Master
510(k) Number K964080
Device Name LORI HEARING AID SIMULATOR
Applicant
Lori Medical Laboratories, Inc.
696 Mendelssohn Ave. N.
Golden Valley,  MN  55427 -4306
Applicant Contact GARY R MAAS
Correspondent
Lori Medical Laboratories, Inc.
696 Mendelssohn Ave. N.
Golden Valley,  MN  55427 -4306
Correspondent Contact GARY R MAAS
Regulation Number874.3330
Classification Product Code
KHL  
Date Received10/11/1996
Decision Date 01/08/1997
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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