FDA 510(k) Application Details - K061275

Device Classification Name Syringe, Piston

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510(K) Number K061275
Device Name Syringe, Piston
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 880.5860

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Classification Product Code FMF
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Date Received 05/08/2006
Decision Date 07/19/2006
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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