FDA 510(k) Application Details - K062984

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K062984
Device Name Needle, Hypodermic, Single Lumen
Applicant MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact LARA N SIMMONS
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 09/29/2006
Decision Date 11/13/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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