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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 K211270
Device Name CIV-Clear cover
Applicant
CIVCO Medical Instruments Co., Inc.
102 First Street South
Kalona,  IA  52247
Applicant Contact Jim Leong
Correspondent
CIVCO Medical Instruments Co., Inc.
102 First Street South
Kalona,  IA  52247
Correspondent Contact Jim Leong
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/27/2021
Decision Date 09/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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