FDA 510(k) Application Details - K120079

Device Classification Name	Tube, Tracheostomy (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K120079
Device Name	Tube, Tracheostomy (W/Wo Connector)
Applicant	PRIMED HALBERSTADT MEDIZINTECHNIK GMBH STRASSE DES 20. JULI NR.1 HALBERSTADT 38820 DE Other 510(k) Applications for this Company
Contact	ALEXANDRA SINGER Other 510(k) Applications for this Contact
Regulation Number	868.5800   More FDA Info for this Regulation Number
Classification Product Code	BTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2012
Decision Date	05/24/2012
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