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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K831896
Device Name COMPACT FOUR
Applicant
NICOLET BIOMEDICAL INSTRUMENTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
NICOLET BIOMEDICAL INSTRUMENTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number882.1870
Classification Product Code
GWF  
Date Received06/14/1983
Decision Date 07/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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