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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 K781667
Device Name AMPLAID MARK 4 AND MARK 5
Applicant
AMPLAID USA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMPLAID USA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received09/25/1978
Decision Date 11/03/1978
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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