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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 K935719
Device Name DAIL A HEARING SCREENING TEST
Applicant
OCCUPATIONAL HEARING SERVICES
300 S. CHESTER RD.
SWARTHMORE,  PA  19081
Applicant Contact GEORGE BIDDLE
Correspondent
OCCUPATIONAL HEARING SERVICES
300 S. CHESTER RD.
SWARTHMORE,  PA  19081
Correspondent Contact GEORGE BIDDLE
Regulation Number874.1050
Classification Product Code
EWO  
Date Received11/30/1993
Decision Date 07/07/1994
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
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