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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, female, mini-sling
510(k) Number K191416
Device Name Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
Applicant
Caldera Medical, Inc.
5171 Clareton Drive
Agoura Hills,  CA  91301
Applicant Contact Vicki Gail
Correspondent
Caldera Medical, Inc.
5171 Clareton Drive
Agoura Hills,  CA  91301
Correspondent Contact Vicki Gail
Regulation Number878.3300
Classification Product Code
PAH  
Subsequent Product Code
PWJ  
Date Received05/28/2019
Decision Date 02/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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