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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 K041244
Device Name POLYGRAM NET BIOFEEDBACK APPLICATION
Applicant
MEDTRONIC VASCULAR
4000 LEXINGTON AVE., NORTH
SHOREVIEW,  MN  55126 -2893
Applicant Contact JULIE GOODE
Correspondent
MEDTRONIC VASCULAR
4000 LEXINGTON AVE., NORTH
SHOREVIEW,  MN  55126 -2893
Correspondent Contact JULIE GOODE
Regulation Number882.5050
Classification Product Code
HCC  
Subsequent Product Code
FFX  
Date Received05/11/2004
Decision Date 08/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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