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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 K950080
Device Name VIP
Applicant
BELL HEARING INSTRUMENTS, INC.
2796 SUMMERDALE DR.
CLEARWATER,  FL  33761
Applicant Contact WILLIAM A BELL
Correspondent
BELL HEARING INSTRUMENTS, INC.
2796 SUMMERDALE DR.
CLEARWATER,  FL  33761
Correspondent Contact WILLIAM A BELL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/10/1995
Decision Date 02/08/1995
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
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