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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 K050969
Device Name INCLOSE SURGICAL MESH SYSTEM
Applicant
ANULEX TECHNOLOGIES, INC
5600 ROWLAND ROAD, STE 280
MINNETONKA,  MN  55343
Applicant Contact TIM MILLER
Correspondent
ANULEX TECHNOLOGIES, INC
5600 ROWLAND ROAD, STE 280
MINNETONKA,  MN  55343
Correspondent Contact TIM MILLER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/18/2005
Decision Date 08/18/2005
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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