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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
Device Name DESARA MESH MODEL: CAL-DS01
Applicant
CALDERA MEDICAL, INC.
28632 ROADSIDE DR., SUITE 260
AGOURA HILLS,  CA  91301
Applicant Contact VICKI GAIL
Correspondent
CALDERA MEDICAL, INC.
28632 ROADSIDE DR., SUITE 260
AGOURA HILLS,  CA  91301
Correspondent Contact VICKI GAIL
Regulation Number878.3300
Classification Product Code
OTN  
Date Received04/26/2010
Decision Date 05/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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