FDA 510(k) Application Details - K014102

Device Classification Name	Tube Tracheostomy And Tube Cuff   More FDA Info for this Device
510(K) Number	K014102
Device Name	Tube Tracheostomy And Tube Cuff
Applicant	ATOS MEDICAL AB KRAFTGATAN 8 HORBY SE-242 22 SE Other 510(k) Applications for this Company
Contact	EDDY ABERG Other 510(k) Applications for this Contact
Regulation Number	868.5800   More FDA Info for this Regulation Number
Classification Product Code	JOH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2001
Decision Date	02/21/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review