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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dura substitute
510(k) Number K973706
Device Name DURA-GUARD-DURAL REPAIR PATCH
Applicant
BIO-VASCULAR, INC.
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Applicant Contact BARBARA ATZENHOEFER
Correspondent
BIO-VASCULAR, INC.
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Correspondent Contact BARBARA ATZENHOEFER
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received09/29/1997
Decision Date 12/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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