FDA 510(k) Application Details - K072487

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K072487
Device Name Needle, Hypodermic, Single Lumen
Applicant PYNG MEDICAL CORP.
#7-13511 CRESTWOOD PL
RICHMOND, B.C. V6V 2E9 CA
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Contact MAYA BUTTERFIELD
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 09/04/2007
Decision Date 02/13/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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