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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 K013477
Device Name TOCO LITE, MODEL TD-01
Applicant
Ventrex, Inc.
3007 Bunsen Ave., Unit L & K
Ventura,  CA  93003
Applicant Contact ROBERT GUTHRIE
Correspondent
Ventrex, Inc.
3007 Bunsen Ave., Unit L & K
Ventura,  CA  93003
Correspondent Contact ROBERT GUTHRIE
Regulation Number884.2720
Classification Product Code
HFM  
Date Received10/19/2001
Decision Date 01/17/2002
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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