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FDA 510(k) Application Details - K231255
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K231255
Device Name
Needle, Hypodermic, Single Lumen
Applicant
Novo Nordisk Inc.
P.O Box 846
Plainsboro, NJ 08536 US
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Contact
Hiral Palkhiwala Shah
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
05/01/2023
Decision Date
08/25/2023
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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