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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, vascular graft, of 6mm and greater diameter
510(k) Number K091491
Device Name HERO VASCULAR ACCESS DEVICE
Applicant
HEMOSPHERE INC
6545 CITY WEST PARKWAY
EDEN PRAIRIE,  MN  55344
Applicant Contact W. ALLEN PUTNAM
Correspondent
HEMOSPHERE INC
6545 CITY WEST PARKWAY
EDEN PRAIRIE,  MN  55344
Correspondent Contact W. ALLEN PUTNAM
Regulation Number870.3450
Classification Product Code
DSY  
Subsequent Product Codes
LJS   MSD  
Date Received05/20/2009
Decision Date 07/31/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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