FDA 510(k) Application Details - K011781

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K011781
Device Name Coil, Magnetic Resonance, Specialty
Applicant SURGI-VISION, INC.
20 FIRSTFIELD RD. SUITE 200
GAITHERSBURG, MD 20878 US
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Contact NANCY E TAYLOR
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 06/07/2001
Decision Date 08/31/2001
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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