510(k) K982614

Device: RUSCH POLYFLEX STENT KIT
Applicant: RUSCH INTL.
510(k) number: K982614
Product code: NYT
Decision: Substantially Equivalent (SESE)
Decision date: 1998-12-04
Date received: 1998-07-27
Regulation: 878.3720
Classification name: Prosthesis, Tracheal, Expandable, Polymeric
Medical specialty: General & Plastic Surgery
Review panel: General & Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: KARENANN J BROZOWSKI
Address: Tall Pines Park Jeffrey NH US 03452 03452

FDA Registration Numbers#

2024024
3006017180
2011171

Source Documents#

Other 510(k) Records For Product Code NYT #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K013266	RUSCH POLYFLEX STENT KIT	Rusch Intl.	2001-11-27
K953593	RUSCH TRACHEAL BRONCHIAL Y STENT	Rusch, Inc.	1995-10-13

Legacy Summary#

summary

FDA Review#

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