FDA 510(k) Application Details - K954661

Device Classification Name	Tube Tracheostomy And Tube Cuff   More FDA Info for this Device
510(K) Number	K954661
Device Name	Tube Tracheostomy And Tube Cuff
Applicant	ZIPPER MEDICAL, INC. 10109 DAY AVE. SILVER SPRING, MD 20910-1041 US Other 510(k) Applications for this Company
Contact	GREG DOLL 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	10/10/1995
Decision Date	01/19/1996
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