FDA 510(k) Application Details - K960793

Device Classification Name	Enzymatic, Carbon-Dioxide   More FDA Info for this Device
510(K) Number	K960793
Device Name	Enzymatic, Carbon-Dioxide
Applicant	SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), QUEBEC, CANADA H8T 2V5 CA Other 510(k) Applications for this Company
Contact	MARCIA J ARENTZ Other 510(k) Applications for this Contact
Regulation Number	862.1160   More FDA Info for this Regulation Number
Classification Product Code	KHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/1996
Decision Date	03/11/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review