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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 K944222
Device Name CODMAN-MEDOS VALVE SHUNT SYSTEM
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
41 PACELLA PARK DR.
RANDOLPH IND. PARK
RANDOLPH,  MA  02368
Applicant Contact PATRICIA BANKERT
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
41 PACELLA PARK DR.
RANDOLPH IND. PARK
RANDOLPH,  MA  02368
Correspondent Contact PATRICIA BANKERT
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/30/1994
Decision Date 07/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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