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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K233652
Device Name Contour Hand/Wrist (Q7000232)
Applicant
Quality Electrodynamics
6655 Beta Drive
Suite 100
Mayfield Village,  OH  44143
Applicant Contact JoVanna Boudreaux
Correspondent
Quality Electrodynamics
6655 Beta Drive
Suite 100
Mayfield Village,  OH  44143
Correspondent Contact JoVanna Boudreaux
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/14/2023
Decision Date 02/16/2024
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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