FDA 510(k) Application Details - K991027

Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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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
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Regulation Number 870.3450

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Classification Product Code DSY
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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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