FDA 510(k) Application Details - K013124

Device Classification Name Fluorometry, Morphine

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510(K) Number K013124
Device Name Fluorometry, Morphine
Applicant BRANAN MEDICAL CORP.
10015 MUIRLANDS RD., SUITE E
IRVINE, CA 92618 US
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Contact RAPHAEL WONG
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Regulation Number 862.3640

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Classification Product Code DJJ
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Date Received 09/19/2001
Decision Date 11/07/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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