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FDA 510(k) Application Details - K213156
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K213156
Device Name
Needle, Hypodermic, Single Lumen
Applicant
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417 US
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Contact
Mark William
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
FMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/20/2021
Decision Date
12/08/2021
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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