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FDA 510(k) Application Details - K031850
Device Classification Name
Dura Substitute
More FDA Info for this Device
510(K) Number
K031850
Device Name
Dura Substitute
Applicant
COOK BIOTECH, INC.
3055 KENT AVE.
WEST LAFAYETTE, IN 47906-1076 US
Other 510(k) Applications for this Company
Contact
MARK BLEYER
Other 510(k) Applications for this Contact
Regulation Number
882.5910
More FDA Info for this Regulation Number
Classification Product Code
GXQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2003
Decision Date
09/08/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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