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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K233109
Device Name TP Pivot Pro™ Needle Guide
Applicant
Civco Medical Solutions
102 First St. S.
Kalona,  IA  52247
Applicant Contact James Leong
Correspondent
Civco Medical Solutions
102 First St. S.
Kalona,  IA  52247
Correspondent Contact James Leong
Regulation Number892.1570
Classification Product Code
ITX  
Date Received09/27/2023
Decision Date 12/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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