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FDA 510(k) Application Details - K970851
Device Classification Name
Dura Substitute
More FDA Info for this Device
510(K) Number
K970851
Device Name
Dura Substitute
Applicant
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO, CA 94080 US
Other 510(k) Applications for this Company
Contact
VICTORIA MACKINNON
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
03/07/1997
Decision Date
12/09/1997
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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