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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 K011069
Device Name AQUASENS FLUID MONITORING SYSTEM
Applicant
DAVOL, INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Applicant Contact LUCINDA L FOX
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number884.1700
Classification Product Code
HIG  
Date Received04/09/2001
Decision Date 08/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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