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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Assistive Listening
510(k) Number K970340
Device Name AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
Applicant
BELLAB
GUSTAF WERNERS GATA 2
S-421 32 V. FROLUNDA
GOTHENBURG,  SE
Applicant Contact MARTIN ERIKSSON
Correspondent
BELLAB
GUSTAF WERNERS GATA 2
S-421 32 V. FROLUNDA
GOTHENBURG,  SE
Correspondent Contact MARTIN ERIKSSON
Regulation Number874.3320
Classification Product Code
LZI  
Date Received01/29/1997
Decision Date 03/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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