FDA 510(k) Application Details - K113644

Device Classification Name	Cuff, Tracheal Tube, Inflatable   More FDA Info for this Device
510(K) Number	K113644
Device Name	Cuff, Tracheal Tube, Inflatable
Applicant	INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. BETHEL PARK, PA 15102 US Other 510(k) Applications for this Company
Contact	DORIS F WALTER Other 510(k) Applications for this Contact
Regulation Number	868.5750   More FDA Info for this Regulation Number
Classification Product Code	BSK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2011
Decision Date	01/26/2012
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