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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, polymeric
510(k) Number K021835
Device Name BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
Original Applicant
BRENNEN MEDICAL, INC.
1290 hammond rd.
st. paul,  MN  55110
Original Contact phillip b lawin
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/04/2002
Decision Date 10/17/2002
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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