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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 K121928
Device Name DESARA SL
Applicant
Caldera Medical, Inc.
5171 Clareton Dr.
Agoura Hills,  CA  91301
Applicant Contact VICKI GAIL
Correspondent
Caldera Medical, Inc.
5171 Clareton Dr.
Agoura Hills,  CA  91301
Correspondent Contact VICKI GAIL
Regulation Number878.3300
Classification Product Code
OTN  
Date Received07/02/2012
Decision Date 02/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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