FDA 510(k) Application Details - K042844

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K042844
Device Name Coil, Magnetic Resonance, Specialty
Applicant GE MEDICAL SYSTEMS, INC.
P.O. BOX 414
MILWAUKEE, WI 53201 US
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Contact LARRY KROGER
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 10/15/2004
Decision Date 11/03/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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