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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
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