FDA 510(k) Application Details - K090080

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K090080
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant MRI-TECH SP. ZO.O.
206 - 3820 CAMBIE STREET
VANCOUVER, BC V5Z 2X7 CA
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Contact ANITA CHAN
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 01/12/2009
Decision Date 03/23/2009
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 N
Expedited Review

FDA Source Information for K090080


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