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FDA 510(k) Application Details - K210399
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K210399
Device Name
Needle, Hypodermic, Single Lumen
Applicant
Owen Mumford Ltd
Brook Hill
Woodstock OX20 1TU GB
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Contact
Darren Mansell
Other 510(k) Applications for this Contact
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
02/10/2021
Decision Date
09/17/2021
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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