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FDA 510(k) Application Details - K992173
Device Classification Name
Shunt, Central Nervous System And Components
More FDA Info for this Device
510(K) Number
K992173
Device Name
Shunt, Central Nervous System And Components
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact
LAURA O'GRADY
Other 510(k) Applications for this Contact
Regulation Number
882.5550
More FDA Info for this Regulation Number
Classification Product Code
JXG
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More FDA Info for this Product Code
Date Received
06/28/1999
Decision Date
04/07/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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