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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 K913245
Device Name MODEL 80 HEARING AID DISPENSING SYSTEM
Applicant
3M Company
3m Center
Bldg. 275-3se-08
St. Paul,  MN  55144
Applicant Contact RALPH FRAVEL
Correspondent
3M Company
3m Center
Bldg. 275-3se-08
St. Paul,  MN  55144
Correspondent Contact RALPH FRAVEL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/22/1991
Decision Date 10/18/1991
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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