FDA 510(k) Application Details - K152300

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K152300
Device Name	Calculator, Drug Dose
Applicant	GLYTEC, LLC 770 PELHAM ROAD, SUITE 210 GREENVILLE, SC 29615 US Other 510(k) Applications for this Company
Contact	JULIE GLENDRANGE Other 510(k) Applications for this Contact
Regulation Number	868.1890   More FDA Info for this Regulation Number
Classification Product Code	NDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2015
Decision Date	08/04/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review