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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
510(k) Number K021160
Device Name DERMMATRIX SURGICAL MESH
Applicant
CARBON MEDICAL TECHNOLOGIES, INC.
1290 HAMMOND RD.
ST. PAUL,  MN  55110
Applicant Contact KAREN E PETERSON
Correspondent
CARBON MEDICAL TECHNOLOGIES, INC.
1290 HAMMOND RD.
ST. PAUL,  MN  55110
Correspondent Contact KAREN E PETERSON
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/11/2002
Decision Date 06/12/2002
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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