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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 K031213
Device Name AQUASENS FLUID MONITORING SYSTEM
Applicant
Davol, Inc.
Subsidiary Of C.R. Bard
100 Sockanossett Crossroad
Cranston,  RI  02920
Applicant Contact BRIAN A KANERVIKO
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number884.1700
Classification Product Code
HIG  
Date Received04/17/2003
Decision Date 04/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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