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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K011823
Device Name BIOREHAB SYSTEM
Applicant
NICOLET BIOMEDICAL, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Applicant Contact Gary J Syring
Correspondent
NICOLET BIOMEDICAL, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Correspondent Contact Gary J Syring
Regulation Number882.5050
Classification Product Code
HCC  
Date Received06/11/2001
Decision Date 09/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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