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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 K953543
Device Name 3M MODEL 8200P MULTIPRO BTE
Applicant
3M COMPANY
3M CENTER, BLDG. 260-6A-19
ST. PAUL,  MN  55144 -1000
Applicant Contact JOYCE K EYERLY
Correspondent
3M COMPANY
3M CENTER, BLDG. 260-6A-19
ST. PAUL,  MN  55144 -1000
Correspondent Contact JOYCE K EYERLY
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/28/1995
Decision Date 08/23/1995
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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