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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
Applicant
CALDERA MEDICAL, INC.
28632 roadside dr., suite 260
agoura hills,  CA  91301 6099
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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