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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesurgical kit
Generic Namesurgical kit
10480 little patuxent pkwy.
suite 400
columbia, MD 21044
HDE NumberH080005
Date Received12/05/2008
Decision Date03/10/2011
Product Code
PAX[ Registered Establishments with PAX ]
Docket Number 11M0170
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S007 S008 S009