FDA 510(k) Application Details - K982614

Device Classification Name	Prosthesis, Tracheal, Expandable, Polymeric   More FDA Info for this Device
510(K) Number	K982614
Device Name	Prosthesis, Tracheal, Expandable, Polymeric
Applicant	RUSCH INTL. TALL PINES PARK JAFFREY, NH 03452 US Other 510(k) Applications for this Company
Contact	KARENANN J BROZOWSKI Other 510(k) Applications for this Contact
Regulation Number	878.3720   More FDA Info for this Regulation Number
Classification Product Code	NYT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/1998
Decision Date	12/04/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review