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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 K984053
FOIA Releasable 510(k) K984053
Device Name BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
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 Number882.5550
Classification Product Code
JXG  
Subsequent Product Code
GWM  
Date Received11/06/1998
Decision Date 02/04/1999
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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