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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name insufflator, hysteroscopic
510(k) Number K210628
Device Name X-FLO Fluid Management System
Thermedx, LLC
31200 Solon Rd Unit 1
Solon,  OH  44139
Applicant Contact Daniel Marijian
Thermedx, LLC
31200 Solon Rd Unit 1
Solon,  OH  44139
Correspondent Contact Daniel Marijian
Regulation Number884.1700
Classification Product Code
Subsequent Product Codes
Date Received03/02/2021
Decision Date 11/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No