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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
Recalls CDRH Recalls
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