FDA 510(k) Application Details - K130304

Device Classification Name	Airway, Oropharyngeal, Anesthesiology   More FDA Info for this Device
510(K) Number	K130304
Device Name	Airway, Oropharyngeal, Anesthesiology
Applicant	THE LARYNGEAL MASK CO.,LTD. 2917 WECK DR PO BOX 12600 RESEARCH TRIANGLE PARK, NC 27709 US Other 510(k) Applications for this Company
Contact	PAUL DRYDEN Other 510(k) Applications for this Contact
Regulation Number	868.5110   More FDA Info for this Regulation Number
Classification Product Code	CAE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2013
Decision Date	05/30/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review