FDA 510(k) Application Details - K191488

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K191488
Device Name	Needle, Hypodermic, Single Lumen
Applicant	SAM« Medical Products, Inc. 27350 SW 95th Ave, Suite 3038 Wilsonville, OR 97070 US Other 510(k) Applications for this Company
Contact	Jeff Lipps 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	06/04/2019
Decision Date	11/21/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review