FDA 510(k) Application Details - K984257

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K984257
Device Name Coil, Magnetic Resonance, Specialty
Applicant MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA, PA 15051 US
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Contact JIM FERGUSON, JR.
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 11/30/1998
Decision Date 01/25/1999
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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