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FDA 510(k) Application Details - K081401
Device Classification Name
Holder, Head, Neurosurgical (Skull Clamp)
More FDA Info for this Device
510(K) Number
K081401
Device Name
Holder, Head, Neurosurgical (Skull Clamp)
Applicant
INTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536 US
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Contact
HELDER A SOUSA
Other 510(k) Applications for this Contact
Regulation Number
882.4460
More FDA Info for this Regulation Number
Classification Product Code
HBL
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More FDA Info for this Product Code
Date Received
05/19/2008
Decision Date
10/08/2008
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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