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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, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
510(k) Number K072456
Device Name DESARA MESH SLING, MODEL CAL-DS01
Original Applicant
CALDERA MEDICAL, INC.
1205 de la vina
santa barbara,  CA  93101
Original Contact christine emanuel
Regulation Number878.3300
Classification Product Code
OTN  
Date Received08/31/2007
Decision Date 05/08/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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