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FDA 510(k) Application Details - K982282
Device Classification Name
Dura Substitute
More FDA Info for this Device
510(K) Number
K982282
Device Name
Dura Substitute
Applicant
BIO-VASCULAR, INC.
2575 UNIVERSITY AVE.
ST. PAUL, MN 55114-1024 US
Other 510(k) Applications for this Company
Contact
MARY FRICK
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
06/30/1998
Decision Date
07/30/1998
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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