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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 K894748
Device Name IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P
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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