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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 K903474
Device Name BEST LABS MODEL C
Applicant
BEST LABS
P.O. BOX 20468
ST. PETERSBURG,  FL  33742
Applicant Contact HARVEY ROMANEK
Correspondent
BEST LABS
P.O. BOX 20468
ST. PETERSBURG,  FL  33742
Correspondent Contact HARVEY ROMANEK
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/31/1990
Decision Date 11/09/1990
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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