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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 K101169
Model CAL-DS01
Device Name DESARA MESH MODEL: CAL-DS01
Original Applicant
CALDERA MEDICAL, INC.
28632 roadside dr., suite 260
agoura hills,  CA  91301
Original Contact vicki gail
Regulation Number878.3300
Classification Product Code
OTN  
Date Received04/26/2010
Decision Date 05/20/2010
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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