FDA 510(k) Application Details - K102127

Device Classification Name	Changer, Tube, Endotracheal   More FDA Info for this Device
510(K) Number	K102127
Device Name	Changer, Tube, Endotracheal
Applicant	INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. BETHEL PARK, PA 15102 US Other 510(k) Applications for this Company
Contact	DORIS WALTER Other 510(k) Applications for this Contact
Regulation Number	868.5730   More FDA Info for this Regulation Number
Classification Product Code	LNZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2010
Decision Date	08/27/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review