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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 K772169
Device Name AUDIOMETER, RECORDING, AUTOMATIC
Applicant
B&K Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
B&K Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.1050
Classification Product Code
EWO  
Date Received11/18/1977
Decision Date 12/02/1977
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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