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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Auditory Impedance
510(k) Number K953161
Device Name MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION
Applicant
Maico Hearing Instruments, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact MIKE CZURA
Correspondent
Maico Hearing Instruments, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact MIKE CZURA
Regulation Number874.1090
Classification Product Code
ETY  
Date Received07/07/1995
Decision Date 07/24/1995
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
Predetermined Change
Control Plan Authorized		 No
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