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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 K053424
Device Name POPMESH
Applicant
CALDERA MEDICAL, INC.
28632 ROADSIDE DR., SUITE 260
AGOURA HILLS,  CA  91301
Applicant Contact MARLA KENGEN
Correspondent
CALDERA MEDICAL, INC.
28632 ROADSIDE DR., SUITE 260
AGOURA HILLS,  CA  91301
Correspondent Contact MARLA KENGEN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/08/2005
Decision Date 02/22/2006
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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