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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 K910247
Device Name ZODIAC 901 MIDDLE-EAR ANALYZER
Applicant
Madsen Electronics (Canada) , Ltd.
908 Nigrara Falls Blvd.
North Tonawanda,  NY  14220
Applicant Contact GEORGE PAY
Correspondent
Madsen Electronics (Canada) , Ltd.
908 Nigrara Falls Blvd.
North Tonawanda,  NY  14220
Correspondent Contact GEORGE PAY
Regulation Number874.1090
Classification Product Code
ETY  
Date Received01/22/1991
Decision Date 06/19/1991
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
Predetermined Change
Control Plan Authorized		 No
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