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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 K946232
Device Name ACURA-EX
Applicant
LUSTGARTEN MULTI-TECH INTL.
73 DALTON RD. STE. 8B
HOLLISTON,  MA  01746
Applicant Contact STEWART LUSTGARTEN
Correspondent
LUSTGARTEN MULTI-TECH INTL.
73 DALTON RD. STE. 8B
HOLLISTON,  MA  01746
Correspondent Contact STEWART LUSTGARTEN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/22/1994
Decision Date 06/30/1995
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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