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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 K884218
Device Name AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Applicant Contact JOHN WATKINS
Correspondent
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Correspondent Contact JOHN WATKINS
Regulation Number874.1050
Classification Product Code
EWO  
Date Received10/06/1988
Decision Date 03/10/1989
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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