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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 K823227
Device Name IMPEDANCE METER ON-1
Applicant
Kells Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kells Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.1090
Classification Product Code
ETY  
Date Received10/29/1982
Decision Date 11/22/1982
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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