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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 K974726
Device Name SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
Applicant
ELEKTA IMPLANTS, SA
6011 CELLINI ST.
CORAL GABLES,  FL  33146
Applicant Contact BARBRA RAMSEYER
Correspondent
ELEKTA IMPLANTS, SA
6011 CELLINI ST.
CORAL GABLES,  FL  33146
Correspondent Contact BARBRA RAMSEYER
Regulation Number882.5550
Classification Product Code
JXG  
Date Received12/18/1997
Decision Date 03/18/1998
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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