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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, auditory, evoked response
510(k) Number K862363
Device Name INSERT EARPHONES
Applicant
CADWELL LABORATORIES, INC.
909 NORTH KELLOGG ST.
KENNEWICK,  WA  99336
Applicant Contact CADWELL, DDS
Correspondent
CADWELL LABORATORIES, INC.
909 NORTH KELLOGG ST.
KENNEWICK,  WA  99336
Correspondent Contact CADWELL, DDS
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received06/23/1986
Decision Date 09/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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