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 Other 510(k) Applications for this Company
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 Other 510(k) Applications for this Device   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