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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 K121532
Device Name HERO GRAFT
Applicant
HEMOSPHERE INC
6545 CITY WEST PARKWAY
EDEN PRAIRIE,  MN  55344
Applicant Contact LAURIE LYNCH
Correspondent
HEMOSPHERE INC
6545 CITY WEST PARKWAY
EDEN PRAIRIE,  MN  55344
Correspondent Contact LAURIE LYNCH
Regulation Number870.3450
Classification Product Code
DSY  
Date Received05/24/2012
Decision Date 06/22/2012
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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