FDA 510(k) Application Details - K970811

Device Classification Name	Tube Tracheostomy And Tube Cuff   More FDA Info for this Device
510(K) Number	K970811
Device Name	Tube Tracheostomy And Tube Cuff
Applicant	PNEUMOCARE, INC. 23991 IRONHEAD LN. LAGUNA NIGUEL, CA 92677 US Other 510(k) Applications for this Company
Contact	JOSEPH H BALES 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	03/05/1997
Decision Date	11/13/1998
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