FDA 510(k) Application Details - K090873

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K090873
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD.
NO. 7, SANJIANFANG NANLI
CHAO YANG DISTRICT, BEIJING 100024 CN
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Contact WANG WEIMIN
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 03/31/2009
Decision Date 04/10/2009
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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