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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ventricular
510(k) Number K983331
Device Name MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102
Applicant
Medtronic PS Medical
125 Cremona Dr.
Goleta,  CA  93117 -5500
Applicant Contact JEFFREY HENDERSON
Correspondent
Medtronic PS Medical
125 Cremona Dr.
Goleta,  CA  93117 -5500
Correspondent Contact JEFFREY HENDERSON
Regulation Number882.4100
Classification Product Code
HCA  
Date Received09/22/1998
Decision Date 12/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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