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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 K982282
Device Name DURA-GUARD - DURAL REPAIR PATCH
Applicant
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114
Applicant Contact MARY FRICK
Correspondent
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114
Correspondent Contact MARY FRICK
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received06/30/1998
Decision Date 07/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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