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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 K140163
Device Name KOALA TOCO
Applicant
CLINICAL INNOVATIONS, LLC
62 FOREST STREET, STE 300
MARLBOROUGH,  MA  01752
Applicant Contact JOANNE BRONIKOWSKI
Correspondent
CLINICAL INNOVATIONS, LLC
62 FOREST STREET, STE 300
MARLBOROUGH,  MA  01752
Correspondent Contact JOANNE BRONIKOWSKI
Regulation Number884.2720
Classification Product Code
HFM  
Date Received01/22/2014
Decision Date 05/29/2014
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
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