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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 K222460
Device Name Intraoperative Ultrasound Probe Cover
Applicant
Exact Medical Manufacturing
21# Qingjjiang Rd
XinBei District
Changzhou Jiangsu,  CN 213022
Applicant Contact Ryan Power
Correspondent
EMMA International Consulting Group
30150 Telegraph Rd.
Suite 120
Bingham Farms,  MI  48025
Correspondent Contact Madison Wheeler
Regulation Number892.1570
Classification Product Code
ITX  
Date Received08/15/2022
Decision Date 05/12/2023
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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