FDA 510(k) Application Details - K971348

Device Classification Name	Airway, Esophageal (Obturator)   More FDA Info for this Device
510(K) Number	K971348
Device Name	Airway, Esophageal (Obturator)
Applicant	GREEN FIELD MEDICAL SOURCING, INC. 910 BOSTON TURNPIKE RD. SHREWSBURY, MA 01545 US Other 510(k) Applications for this Company
Contact	DONALD R GORSUCH Other 510(k) Applications for this Contact
Regulation Number	868.5650   More FDA Info for this Regulation Number
Classification Product Code	CAO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/1997
Decision Date	02/27/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review