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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
Predetermined Change
Control Plan Authorized		 No
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