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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 K080393
Device Name MODIFICATION TO REBOUND HRD
Applicant
Minnesota Medical Development, Inc.
4050 Olson Memorial Highway
Suite 350
Minneapolis,  MN  55422
Applicant Contact JULIE BULVER
Correspondent
Minnesota Medical Development, Inc.
4050 Olson Memorial Highway
Suite 350
Minneapolis,  MN  55422
Correspondent Contact JULIE BULVER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/13/2008
Decision Date 03/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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