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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 K180666
Device Name 48CH Head Coil
Applicant
Ge Healthcare Coils (Usa Instruments, Inc.)
1515 Danner Dr.
Aurora,  OH  44202
Applicant Contact Veronica A. Meridith
Correspondent
Ge Healthcare Coils (Usa Instruments, Inc.)
1515 Danner Dr.
Aurora,  OH  44202
Correspondent Contact Veronica A. Meridith
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/14/2018
Decision Date 04/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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