FDA 510(k) Application Details - K030854

Device Classification Name	Insufflator, Automatic Carbon-Dioxide For Endoscope   More FDA Info for this Device
510(K) Number	K030854
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	JUDY HAUSER 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	03/18/2003
Decision Date	04/16/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review