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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 K091939
Device Name THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
Applicant
THERMEDX, LLC
31200 SOLON ROAD
UNIT 1
SOLON,  OH  44139
Applicant Contact JEFF B WILLIAMS
Correspondent
THERMEDX, LLC
31200 SOLON ROAD
UNIT 1
SOLON,  OH  44139
Correspondent Contact JEFF B WILLIAMS
Regulation Number884.1700
Classification Product Code
HIG  
Date Received06/30/2009
Decision Date 07/23/2010
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
Recalls CDRH Recalls
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