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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Uterine Contraction, External (For Use In Clinic)
510(k) Number K061044
Device Name FEATHERLITE AQUA TOCODYNAMOMETER
Applicant
VENTREX, INC.
3007 BUNSEN AVE.
SUITE K
VENTURA,  CA  93003
Applicant Contact GEORGE AUSTRIA
Correspondent
VENTREX, INC.
3007 BUNSEN AVE.
SUITE K
VENTURA,  CA  93003
Correspondent Contact GEORGE AUSTRIA
Regulation Number884.2720
Classification Product Code
HFM  
Date Received04/14/2006
Decision Date 07/12/2006
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
Predetermined Change
Control Plan Authorized		 No
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