FDA 510(k) Application Details - K970365

Device Classification Name	Tube Tracheostomy And Tube Cuff   More FDA Info for this Device
510(K) Number	K970365
Device Name	Tube Tracheostomy And Tube Cuff
Applicant	PASSY-MUIR, INC. 4521 CAMPUS DR., SUITE 273 IRVINE, CA 92612 US Other 510(k) Applications for this Company
Contact	PATRICIA E PASSY 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	01/31/1997
Decision Date	02/12/1997
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