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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 Rd.Side Dr., Suite 260
Agoura Hills,  CA  91301
Applicant Contact VICKI GAIL
Correspondent
Caldera Medical, Inc.
28632 Rd.Side Dr., Suite 260
Agoura Hills,  CA  91301
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
Predetermined Change
Control Plan Authorized		 No
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