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510(k) K082127

STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 by Medtronic Neurosurgery — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2008
Date Received
July 29, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

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