FDA 510(k) Application Details - K042009

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K042009
Device Name Coil, Magnetic Resonance, Specialty
Applicant USA INSTRUMENTS, INC.
1515 DANNER DR.
AURORA, OH 44202 US
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Contact JAMES WRENN
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 07/26/2004
Decision Date 08/11/2004
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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