FDA 510(k) Application Details - K101344

Device Classification Name	Calculator, Drug Dose   More FDA Info for this Device
510(K) Number	K101344
Device Name	Calculator, Drug Dose
Applicant	GLYTEC, LLC (FORMALLY KNOWN AS GLUCOTEC, INC.) 2607 WOODRUFF RD SIMPSONVILLE, SC 29681 US Other 510(k) Applications for this Company
Contact	WILLIAM MATTHEWS 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	05/13/2010
Decision Date	06/28/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review