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FDA 510(k) Application Details - K090506

Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)

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510(K) Number K090506
Device Name Holder, Head, Neurosurgical (Skull Clamp)
Applicant INTEGRA LIFESCIENCES CORPORATION
4900 CHARLEMAR DR.,
BUILDING A
CINCINNATI, OH US
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Contact HELDER A SOUSA
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Regulation Number 882.4460

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Classification Product Code HBL
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Date Received 02/25/2009
Decision Date 04/20/2009
Decision SE - Substantially Equivalent
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review N



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