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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 K031616
Device Name IUR FLUID MANAGEMENT SYSTEM
Applicant
W.O.M. World of Medicine AG
320 N. Columbus St.
Alexandria,  VA  22314
Applicant Contact SUSANNE RAAB
Correspondent
W.O.M. World of Medicine AG
320 N. Columbus St.
Alexandria,  VA  22314
Correspondent Contact SUSANNE RAAB
Regulation Number884.1700
Classification Product Code
HIG  
Date Received05/23/2003
Decision Date 08/13/2003
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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