FDA 510(k) Application Details - K013219

Device Classification Name	Insufflator, Automatic Carbon-Dioxide For Endoscope   More FDA Info for this Device
510(K) Number	K013219
Device Name	Insufflator, Automatic Carbon-Dioxide For Endoscope
Applicant	E-Z-EM, INC. 717 MAIN ST. WESTBURY, NY 11590 US Other 510(k) Applications for this Company
Contact	ROBERT WILLIAMS Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2001
Decision Date	02/19/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review