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FDA 510(k) Application Details - K032693
Device Classification Name
Dura Substitute
More FDA Info for this Device
510(K) Number
K032693
Device Name
Dura Substitute
Applicant
INTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536 US
Other 510(k) Applications for this Company
Contact
DIANA M BORDON
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
09/02/2003
Decision Date
09/30/2003
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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