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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
Applicant
BRENNEN MEDICAL, INC.
1290 HAMMOND RD.
ST. PAUL,  MN  55110
Applicant Contact PHILLIP B LAWIN
Correspondent
BRENNEN MEDICAL, INC.
1290 HAMMOND RD.
ST. PAUL,  MN  55110
Correspondent Contact PHILLIP B LAWIN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/04/2002
Decision Date 10/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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