FDA 510(k) Application Details - K994315

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K994315
Device Name Coil, Magnetic Resonance, Specialty
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN, NJ 08830 US
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Contact JAMIE YIEH
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 12/22/1999
Decision Date 02/04/2000
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



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