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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 K172048
Device Name FluidSmart
Applicant
Thermedx, LLC
31200 Solon Rd., Unit 1
Solon,  OH  44139
Applicant Contact Homer Gregory
Correspondent
Thermedx, LLC
31200 Solon Rd., Unit 1
Solon,  OH  44139
Correspondent Contact Homer Gregory
Regulation Number884.1700
Classification Product Code
HIG  
Subsequent Product Codes
HRX   LGZ  
Date Received07/06/2017
Decision Date 09/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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