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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 K910762
Device Name 3M MODEL 8244 ITE HEARING AID
Applicant
3M COMPANY
3M CENTER
BLDG. 275-3SE-08
ST. PAUL,  MN  55144 -1000
Applicant Contact JOYCE K EYERLY
Correspondent
3M COMPANY
3M CENTER
BLDG. 275-3SE-08
ST. PAUL,  MN  55144 -1000
Correspondent Contact JOYCE K EYERLY
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/19/1991
Decision Date 02/28/1991
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
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