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FDA 510(k) Application Details - K991027
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
More FDA Info for this Device
510(K) Number
K991027
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
IMPRA, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE, AZ 85281 US
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Contact
KRISTI M KISTNER
Other 510(k) Applications for this Contact
Regulation Number
870.3450
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Classification Product Code
DSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/29/1999
Decision Date
04/22/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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