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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, Metal
510(k) Number K063461
Device Name ANOVA CONTAINMENT DEVICE
Applicant
ANOVA CORPORATION
2001 PENNSYLVANIA AVE., NW
WASHINGTON,  DC  20006
Applicant Contact CAMPBELL TUSKEY
Correspondent
ANOVA CORPORATION
2001 PENNSYLVANIA AVE., NW
WASHINGTON,  DC  20006
Correspondent Contact CAMPBELL TUSKEY
Regulation Number878.3300
Classification Product Code
EZX  
Subsequent Product Code
KWQ  
Date Received11/15/2006
Decision Date 08/13/2009
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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