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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 K854124
Device Name CRAIGWELL AID HA300
Applicant
CRAIGWELL ELECTRONICS, LTD.
MEADOW VALE HOUSE
LOWER BLUNSDON, NR SWINDON
WILTSHIRE SN2 4BJ,  GB
Applicant Contact WELLBURN
Correspondent
CRAIGWELL ELECTRONICS, LTD.
MEADOW VALE HOUSE
LOWER BLUNSDON, NR SWINDON
WILTSHIRE SN2 4BJ,  GB
Correspondent Contact WELLBURN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/09/1985
Decision Date 03/26/1986
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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