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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 K222052
Device Name VitroPRO
Applicant
CIVCO Medical Instruments Co., Inc.
102 First St. S.
Kalona,  IA  52247
Applicant Contact Jim Leong
Correspondent
CIVCO Medical Instruments Co., Inc.
102 First St. S.
Kalona,  IA  52247
Correspondent Contact Jim Leong
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
MQE  
Date Received07/12/2022
Decision Date 11/22/2022
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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