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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 K950956
Device Name DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE
Applicant
Bio-Vascular, Inc.
2670 Patton Rd.
St. Paul,  MN  55113
Applicant Contact BRUCE A MACFARLANE
Correspondent
Bio-Vascular, Inc.
2670 Patton Rd.
St. Paul,  MN  55113
Correspondent Contact BRUCE A MACFARLANE
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received03/02/1995
Decision Date 06/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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