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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
Original Applicant
CARBON MEDICAL TECHNOLOGIES, INC.
1290 hammond rd.
st. paul,  MN  55110
Original Contact karen e peterson
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/11/2002
Decision Date 06/12/2002
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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