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FDA 510(k) Application Details - K030289
Device Classification Name
Shunt, Central Nervous System And Components
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510(K) Number
K030289
Device Name
Shunt, Central Nervous System And Components
Applicant
INTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536 US
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Contact
DONNA WALLACE
Other 510(k) Applications for this Contact
Regulation Number
882.5550
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Classification Product Code
JXG
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More FDA Info for this Product Code
Date Received
01/28/2003
Decision Date
02/26/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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