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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
Applicant
Thermedx, LLC
31200 Solon Rd., Unit 1
Solon,  OH  44139
Applicant Contact Daniel Marijian
Correspondent
Thermedx, LLC
31200 Solon Rd., Unit 1
Solon,  OH  44139
Correspondent Contact Daniel Marijian
Regulation Number884.1700
Classification Product Code
HIG  
Subsequent Product Codes
HRX   LGZ  
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
Predetermined Change
Control Plan Authorized		 No
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