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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 K112609
Model CAL-DS01
Device Name DESARA MESH
Applicant
CALDERA MEDICAL, INC.
5171 clareton drive
agoura hills,  CA  91301
Contact vicki gail
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OTN  
Date Received09/08/2011
Decision Date 09/30/2011
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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