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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name magnet, test, pacemaker
510(k) Number K092364
Device Name MODEL 220 PATIENT MAGNET
Applicant
CYBERONICS, INC.
100 CYBERONICS BLVD.
HOUSTON,  TX  77058 -2017
Applicant Contact KAREN STUEBER
Correspondent
CYBERONICS, INC.
100 CYBERONICS BLVD.
HOUSTON,  TX  77058 -2017
Correspondent Contact KAREN STUEBER
Regulation Number870.3690
Classification Product Code
DTG  
Date Received08/05/2009
Decision Date 11/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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