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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 K940670
Device Name EARCRAFT HEARING AID
Applicant
EARCRAFT, INC.
103 WATER ST. SUITE 204
HALLOWELL,  ME  04347
Applicant Contact ERIC WEEKS
Correspondent
EARCRAFT, INC.
103 WATER ST. SUITE 204
HALLOWELL,  ME  04347
Correspondent Contact ERIC WEEKS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/16/1994
Decision Date 08/04/1994
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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