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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shunt, central nervous system and components
510(k) Number K981046
Device Name MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118
Applicant
MEDTRONIC PS MEDICAL
125 CREMONA DR.
GOLETA,  CA  93117 -5500
Applicant Contact RICHARD M RUEDY
Correspondent
MEDTRONIC PS MEDICAL
125 CREMONA DR.
GOLETA,  CA  93117 -5500
Correspondent Contact RICHARD M RUEDY
Regulation Number882.5550
Classification Product Code
JXG  
Date Received03/20/1998
Decision Date 06/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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