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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Nasopharyngeal
510(k) Number K030517
Device Name BALL RECORDING ELECTRODE/STIMULATION PROBE
Applicant
Viasys Healthcare, Inc.
800 Levanger Ln.
Stoughton,  WI  53589
Applicant Contact Gary Syring
Correspondent
Viasys Healthcare, Inc.
800 Levanger Ln.
Stoughton,  WI  53589
Correspondent Contact Gary Syring
Regulation Number882.1340
Classification Product Code
GZK  
Date Received02/19/2003
Decision Date 08/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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