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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 K101462
Device Name ASCEND BLUE AC MESH; ASCEND BLUE PC MESH
Applicant
CALDERA MEDICAL, INC.
28632 ROADSIDE DR., SUITE 260
AGOURA HILLS,  CA  91301 -6099
Applicant Contact VICKI GAIL
Correspondent
CALDERA MEDICAL, INC.
28632 ROADSIDE DR., SUITE 260
AGOURA HILLS,  CA  91301 -6099
Correspondent Contact VICKI GAIL
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/26/2010
Decision Date 08/16/2010
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
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