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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 K911182
Device Name NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS
Applicant
MAGNATONE HEARING AID CORP.
170 N. CYPRESS WAY
P.O. BOX 180964
CASSELBERRY,  FL  32718 -0964
Applicant Contact TONY QUICK
Correspondent
MAGNATONE HEARING AID CORP.
170 N. CYPRESS WAY
P.O. BOX 180964
CASSELBERRY,  FL  32718 -0964
Correspondent Contact TONY QUICK
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/18/1991
Decision Date 05/09/1991
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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