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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Intrauterine
510(k) Number K250897
Device Name Koala Intrauterine Pressure Catheter (IPC-5000E)
Applicant
Clinical Innovations, LLC
747 W 4170 S
Murray,  UT  84047
Applicant Contact Alex Garrett
Correspondent
Clinical Innovations, LLC
747 W 4170 S
Murray,  UT  84047
Correspondent Contact Alex Garrett
Regulation Number884.2700
Classification Product Code
HFN  
Date Received03/25/2025
Decision Date 05/22/2025
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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