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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 Apical Vaginal And Uterine Prolapse, Transabdominally Placed
510(k) Number K150016
Device Name Vertessa Lite
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
OTO  
Date Received01/05/2015
Decision Date 04/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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