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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K895784
Device Name IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3
Applicant
SINGER MEDICAL PRODUCTS, INC.
790 MAPLE LN.
BENSENVILLE,  IL  60106
Applicant Contact JAMES I BECK
Correspondent
SINGER MEDICAL PRODUCTS, INC.
790 MAPLE LN.
BENSENVILLE,  IL  60106
Correspondent Contact JAMES I BECK
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/26/1989
Decision Date 12/05/1989
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
Predetermined Change
Control Plan Authorized		 No
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