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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 K033704
Device Name MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
Applicant
VYGON US LLC
2495 GENERAL ARMSTEAD AVE.
NORRISTOWN,  PA  19403
Applicant Contact COURTNEY SMITH
Correspondent
VYGON US LLC
2495 GENERAL ARMSTEAD AVE.
NORRISTOWN,  PA  19403
Correspondent Contact COURTNEY SMITH
Regulation Number882.5550
Classification Product Code
JXG  
Date Received11/25/2003
Decision Date 05/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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