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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 K022863
Device Name HTS COIL
Applicant
Jockey Club Mri Engineering Center
Pokfulam Rd.
University Of Hong Kong
Hong Kong,  HK
Applicant Contact EDWARD S YANG
Correspondent
Jockey Club Mri Engineering Center
Pokfulam Rd.
University Of Hong Kong
Hong Kong,  HK
Correspondent Contact EDWARD S YANG
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/28/2002
Decision Date 02/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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