FDA 510(k) Application Details - K200017

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K200017
Device Name	Needle, Hypodermic, Single Lumen
Applicant	Eclipse MedCorp, LLC 5916 Stone Creek Drive Suite#120 The Colony, TX 75056 US Other 510(k) Applications for this Company
Contact	John Tepper 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	01/03/2020
Decision Date	11/05/2020
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