FDA 510(k) Application Details - K071882

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K071882
Device Name Coil, Magnetic Resonance, Specialty
Applicant SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
6A, BUILDING-2, NO. 398
TIANLIN RD
SHANGHAI 200233 CN
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Contact SONGTAO ZHANG
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 07/09/2007
Decision Date 07/18/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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