FDA 510(k) Application Details - K001097

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K001097
Device Name Coil, Magnetic Resonance, Specialty
Applicant IMAGE-GUIDED NEUROLOGICS, INC.
2290 EAU GALLIE BLVD.
MELBOURNE, FL 32935 US
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Contact DAVID M LEE
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 04/04/2000
Decision Date 01/18/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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