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FDA 510(k) Application Details - K991413
Device Classification Name
Dura Substitute
More FDA Info for this Device
510(K) Number
K991413
Device Name
Dura Substitute
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM, MA 02767 US
Other 510(k) Applications for this Company
Contact
DEANA BOUSHELL
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
04/23/1999
Decision Date
03/13/2000
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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