FDA 510(k) Application Details - K192382

Device Classification Name	More FDA Info for this Device
510(K) Number	K192382
Device Name	CapKlenZ
Applicant	Star Mountain Medical, Inc. 9005 Montana Ave, Suite A El Paso, TX 79925 US Other 510(k) Applications for this Company
Contact	Aaron Chiu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2019
Decision Date	04/20/2020
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