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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 K211969
Device Name EMM Ultrasonic Transducer Cover
Applicant
Exact Medical Manufacturing
4917 William St. - Suite C
Lancaster,  NY  14086
Applicant Contact Ryan Power
Correspondent
Global Quality and Regulatory Services
10 Scenic Way
Monroe,  NJ  08831
Correspondent Contact Abdel B Halim
Regulation Number892.1570
Classification Product Code
ITX  
Date Received06/24/2021
Decision Date 08/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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