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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
Models CAL-AC02, CAL-PC02
Device Name ASCEND BLUE AC MESH; ASCEND BLUE PC MESH
Original Applicant
CALDERA MEDICAL, INC.
28632 roadside dr., suite 260
agoura hills,  CA  91301 6099
Original Contact vicki gail
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/26/2010
Decision Date 08/16/2010
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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