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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name hysteroscope (and accessories)
510(k) Number K192811
Device Name BenestaTM Tissue Removal Device
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 Number884.1690
Classification Product Code
HIH  
Date Received09/30/2019
Decision Date 10/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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