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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 K211975
Device Name Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
Applicant
Caldera Medical, Inc.
4360 Park Terrace Dr.
West Lake Village,  CA  91361
Applicant Contact Vicki Gail
Correspondent
Caldera Medical, Inc.
4360 Park Terrace Dr.
West Lake Village,  CA  91361
Correspondent Contact Vicki Gail
Regulation Number878.3300
Classification Product Code
OTN  
Subsequent Product Code
PWJ  
Date Received06/25/2021
Decision Date 11/10/2021
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
Predetermined Change
Control Plan Authorized		 No
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