FDA 510(k) Application Details - K180683

Device Classification Name	More FDA Info for this Device
510(K) Number	K180683
Device Name	Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
Applicant	Certa Dose, Inc. 7351 E Lowry Blvd. #400 Denver, CO 80230 US Other 510(k) Applications for this Company
Contact	Caleb Hernandez Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2018
Decision Date	11/07/2018
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