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FDA 510(k) Application Details - K952837
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K952837
Device Name
Needle, Hypodermic, Single Lumen
Applicant
EMK ENTERPRISES, LLC.
218 PRINCESS ST.
WILMINGTON, NC 28401 US
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Contact
EVAN M KNOTEK
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Regulation Number
880.5570
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Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
06/19/1995
Decision Date
01/30/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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