FDA 510(k) Application Details - K050476

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K050476
Device Name Coil, Magnetic Resonance, Specialty
Applicant SIEMENS MEDICAL SOLUTION, INC. USA
51 VALLEY STREAM PKWY. E50
MALVERN, PA 19355 US
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Contact ANA LADINO
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 02/24/2005
Decision Date 03/25/2005
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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