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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 K134033
Device Name MIROMATRIX BIOLOGICAL MESH
Applicant
MIROMATRIX MEDICAL INC.
400 N. WASHINGTON ST., STE 100
ALEXANDRIA,  VA  22314
Applicant Contact STEPHEN RHODES
Correspondent
MIROMATRIX MEDICAL INC.
400 N. WASHINGTON ST., STE 100
ALEXANDRIA,  VA  22314
Correspondent Contact STEPHEN RHODES
Regulation Number878.3300
Classification Product Code
FTM  
Date Received12/31/2013
Decision Date 03/31/2014
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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