FDA 510(k) Application Details - K023679

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K023679
Device Name Coil, Magnetic Resonance, Specialty
Applicant W.L. GORE & ASSOCIATES,INC
750 OTT'S CHAPEL RD.
NEWARK, DE 19713 US
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Contact TRACY WOLF
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 11/01/2002
Decision Date 11/18/2002
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 Y
Expedited Review



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