FDA 510(k) Application Details - K961134

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

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510(K) Number K961134
Device Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant C.R. BARD, INC.
25 COMPUTER DR.
HAVERHILL, MA 01832 US
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Contact SANDRA L PERREAND
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Regulation Number 870.3450

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Classification Product Code DSY
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Date Received 03/21/1996
Decision Date 06/19/1996
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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