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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 K853725
Device Name ATRIUM PLASMA TFE SYNTHETIC ARTERY
Applicant
ATRIUM MEDICAL CORP.
17 CLINTON DR.
HOLLIS,  NH  03049
Applicant Contact STEVE HERWECK
Correspondent
ATRIUM MEDICAL CORP.
17 CLINTON DR.
HOLLIS,  NH  03049
Correspondent Contact STEVE HERWECK
Regulation Number870.3450
Classification Product Code
DSY  
Date Received09/06/1985
Decision Date 12/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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